Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 11:16 AM
Study NCT ID:
NCT03302156
Status:
TERMINATED
Last Update Posted:
2023-09-05
First Post:
2017-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PSMA PET and MRI in Gynecological Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esadowski@uwhealth.org', 'phone': '608-263-9028', 'title': 'Elizabeth Sadowski, MD', 'organization': 'UW School of Medicine and Public Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Calculating accuracy, sensitivity and specificity relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.'}}, 'adverseEventsModule': {'timeFrame': 'during research visit, up to 3 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Control Non-Dosimetry Group', 'description': 'The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patient Group', 'description': 'The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnostic Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control Non-Dosimetry Group', 'description': 'The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'OG001', 'title': 'Patient Group', 'description': 'The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'OG002', 'title': 'Dosimetry Group', 'description': 'Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}], 'timeFrame': 'up to 1 day', 'description': 'Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.', 'reportingStatus': 'POSTED', 'populationDescription': 'Calculating accuracy relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.'}, {'type': 'SECONDARY', 'title': 'Biodistribution of PSMA Measured by SUVmax in Normal Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control Non-Dosimetry Group', 'description': 'The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'OG001', 'title': 'Patient Group', 'description': 'The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'OG002', 'title': 'Dosimetry Group', 'description': 'Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}], 'classes': [{'title': 'Aorta at carina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Liver - Right Lobe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.1', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Myometrium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Endometrium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Cervix', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Right Ovary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Corpus Luteum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as only a single participant was analyzed', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Left Ovary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 day', 'description': 'Record the normal biodistribution of PSMA as detected in normal tissue controls, by the resulting PET imaging.', 'unitOfMeasure': 'SUVmax', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This was performed on the entire population of patients recruited in both the Healthy Control and Patient group.'}, {'type': 'SECONDARY', 'title': 'Biodistribution of PSMA Measured by SUVmax in Cancer Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control Non-Dosimetry Group', 'description': 'The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'OG001', 'title': 'Patient Group', 'description': 'The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'OG002', 'title': 'Dosimetry Group', 'description': 'Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': 'NA', 'comment': 'Standard deviation was not calculated as only a single participant was analyzed', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 day', 'description': 'Record the biodistribution of PSMA as detected in cancer tissue, by the resulting PET imaging.', 'unitOfMeasure': 'SUVmax', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This was performed on the "Patient" population. There was only one patient with confirmed ovarian cancer with PSMA uptake.'}, {'type': 'SECONDARY', 'title': 'Radiodosimetry of PSMA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control Non-Dosimetry Group', 'description': 'The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'OG001', 'title': 'Patient Group', 'description': 'The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'OG002', 'title': 'Dosimetry Group', 'description': 'Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}], 'timeFrame': 'up to 1 day', 'description': 'The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this. There were no participants enrolled into the Dosimetry group. The study was terminated early due to low accrual and loss of funding.'}, {'type': 'SECONDARY', 'title': 'Sensitivity and Specificity of PSMA-based PET/MR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control Non-Dosimetry Group', 'description': 'The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'OG001', 'title': 'Patient Group', 'description': 'The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'OG002', 'title': 'Dosimetry Group', 'description': 'Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}], 'timeFrame': 'up to 1 day', 'description': 'Record the distribution of PSMA in cancer tissue.', 'reportingStatus': 'POSTED', 'populationDescription': 'Calculating sensitivity and specificity relies on the IHC staining as the gold standard. IHC staining was not done because the study was terminated due to low recruitment and loss of funds. Because the IHC staining was not performed, there is no gold standard by which to perform accuracy, sensitivity and specificity analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Control Non-Dosimetry Group', 'description': 'The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'FG001', 'title': 'Patient Group', 'description': 'The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'FG002', 'title': 'Dosimetry Group', 'description': 'Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Analysis Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participants With Confirmed Ovarian Cancer With PSMA Uptake', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'no visible evidence of tumor on MRI', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '15 participants were consented from November 2017 to December 2019. Research was suspended in March 2020 per the COVID-19 pandemic. The study opened to enrollment again in June 2022; there were no more participants consented. The investigator terminated the study in January 2023 due to slow accrual of patients with ovarian cancer and due to lack of funding. No participants were enrolled in the Dosimetry group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Control Non-Dosimetry Group', 'description': 'The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'BG001', 'title': 'Patient Group', 'description': 'The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40\n\nPSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '68'}, {'value': '57.3', 'groupId': 'BG001', 'lowerLimit': '36', 'upperLimit': '86'}, {'value': '56.7', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Suspected Participant Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Healthy Controls', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Ovarian Cancer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Endometrial Cancer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Cervical Cancer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Other Cancer', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'study terminated early, no participants enrolled in dosimetry group'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-08', 'size': 1337280, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-10T11:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Slow accrual following suspension per COVID-19', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-08', 'studyFirstSubmitDate': '2017-08-18', 'resultsFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2017-09-29', 'lastUpdatePostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-19', 'studyFirstPostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Accuracy', 'timeFrame': 'up to 1 day', 'description': 'Estimate the frequency with which PSMA PET and MR imaging and final IHC staining disagree in their classifications of presence of disease.'}], 'secondaryOutcomes': [{'measure': 'Biodistribution of PSMA Measured by SUVmax in Normal Tissue', 'timeFrame': 'up to 1 day', 'description': 'Record the normal biodistribution of PSMA as detected in normal tissue controls, by the resulting PET imaging.'}, {'measure': 'Biodistribution of PSMA Measured by SUVmax in Cancer Tissue', 'timeFrame': 'up to 1 day', 'description': 'Record the biodistribution of PSMA as detected in cancer tissue, by the resulting PET imaging.'}, {'measure': 'Radiodosimetry of PSMA', 'timeFrame': 'up to 1 day', 'description': 'The radiodosimetry of PSMA-based 18F-DCFPyL will be measured in normal female controls via the resulting PET images.'}, {'measure': 'Sensitivity and Specificity of PSMA-based PET/MR', 'timeFrame': 'up to 1 day', 'description': 'Record the distribution of PSMA in cancer tissue.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uterine cancer', 'Ovarian cancer', 'Hysterectomy', 'Salpingo-oophorectomy'], 'conditions': ['Gynecologic Cancer']}, 'referencesModule': {'references': [{'pmid': '36512649', 'type': 'DERIVED', 'citation': 'Kunikowska J, Bizon M, Pelka K, Derlatka P, Olszewski M, Krolicki L. 68 Ga-Prostate-Specific Membrane Antigen PET/CT in Ovarian Tumors : Potential to Differentiate Benign and Malignant Tumors Before Surgery: A Preliminary Report. Clin Nucl Med. 2023 Feb 1;48(2):e60-e66. doi: 10.1097/RLU.0000000000004486. Epub 2022 Nov 18.'}], 'seeAlsoLinks': [{'url': 'https://cancer.wisc.edu/', 'label': 'University of Wisconsin Carbone Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research is to determine the accuracy of PSMA positron emission tomography (PET) and multi-parametric magnetic resonance (MR) imaging to detect the presence of gynecological cancer cells in the body.', 'detailedDescription': 'The investigators will evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL, to determine the presence or absence of cancer, the accurate distribution of cancer and the normal biodistribution of PSMA in the abdomen and pelvis on PET imaging.\n\nPSMA, also known as folate hydrolase 1 and glutamate carboxypeptidase II, is an enzyme associated with prostate cancer but has been also found to be expressed in the tumor neovasculature of many different types of non-prostate cancer tumors. PSMA-based 18F-DCFPyL PET demonstrates very high tumor-to-background ratio when studied in other tumors, including prostate tumors.\n\nMR imaging is a highly sensitive and specific imaging modality that can be used for gynecologic cancers. MR images can be obtained in conjunction with PSMA PET, adding additional anatomic and multi-parametric MRI information without the need for a second imaging appointment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for healthy female controls N=12 (includes up to 6 Dosimetry participants):\n\n* Women with no suspected gynecological cancer.\n* No contraindications for MR or PET imaging.\n* Greater than or equal to 18 years of age.\n* Scheduled to undergo a hysterectomy and/or salpingo-oophorectomy\n\nInclusion Criteria for female controls (Dosimetry):\n\n* Women with or without suspected gynecological cancer.\n* No contraindications for MR or PET imaging.\n* Greater than or equal to 18 years of age.\n\nInclusion Criteria for gynecological cancer patients (N=40):\n\n* Women with known or suspected gynecological cancer\n* No contraindications for MR or PET imaging.\n* Greater than or equal to 18 years\n* Have had or are scheduled to undergo a hysterectomy and/or salpingo-oophorectomy\n\nExclusion Criteria:\n\n* Women that are pregnant or breast-feeding.\n* Age \\<18\n* Inability to provide informed consent on their own behalf\n* Severe kidney dysfunction (GFR \\<30 mL/min/1.73m2)'}, 'identificationModule': {'nctId': 'NCT03302156', 'briefTitle': 'PSMA PET and MRI in Gynecological Cancers', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'PSMA Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging in Gynecological Cancers', 'orgStudyIdInfo': {'id': 'UW17017'}, 'secondaryIdInfos': [{'id': '2017-0456', 'type': 'OTHER', 'domain': 'Institutional Review Board'}, {'id': 'A539300', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH\\RADIOLOGY\\RADIOLOGY', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'NCI-2018-00466', 'type': 'REGISTRY', 'domain': 'NCI Trial ID'}, {'id': '06-08-2020', 'type': 'OTHER', 'domain': 'Protocol Version Date'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy Control Non-Dosimetry Group', 'description': 'The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6', 'interventionNames': ['Drug: PSMA-based 18F-DCFPyL PET tracer']}, {'type': 'OTHER', 'label': 'Patient Group', 'description': 'The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40', 'interventionNames': ['Drug: PSMA-based 18F-DCFPyL PET tracer']}, {'type': 'OTHER', 'label': 'Dosimetry Group', 'description': 'Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6', 'interventionNames': ['Drug: PSMA-based 18F-DCFPyL PET tracer']}], 'interventions': [{'name': 'PSMA-based 18F-DCFPyL PET tracer', 'type': 'DRUG', 'otherNames': ['PSMA'], 'description': 'PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer', 'armGroupLabels': ['Dosimetry Group', 'Healthy Control Non-Dosimetry Group', 'Patient Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin, Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Steve Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}, {'name': 'Elizabeth Sadowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}