Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT03262818
Status:
COMPLETED
Last Update Posted:
2018-11-23
First Post:
2017-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-20', 'studyFirstSubmitDate': '2017-08-23', 'studyFirstSubmitQcDate': '2017-08-23', 'lastUpdatePostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure PAI/ultrasound signatures from ovaries prior to surgery', 'timeFrame': 'Prior to surgery (no more than 30 days prior to surgery)', 'description': '-The transvaginal US will be performed by US technologists or radiologists at the Radiology Department and images will be read by one of the study radiologists either Dr. Cary Siegel or Dr. Kathryn Robinson of the Radiology Department. The reading will be categorized as normal, suspicious or highly suspicious. The scores will serve as a baseline comparison of US/PAI technique with the current clinical practice using US. Immediately after the transvaginal US, US/PAI imaging will be performed with the assistance of the US technologist or radiologist.'}], 'secondaryOutcomes': [{'measure': 'Characterize the tissue images with pathologic diagnosis', 'timeFrame': 'At the time of surgery (no more than 30 days after PAI/US)', 'description': '-The in vivo and ex vivo PAI/US images with be compared with final pathologic diagnosis.'}, {'measure': 'Refine the system and imaging algorithms based on the characteristic features of in vivo imaging', 'timeFrame': 'At the time of surgery (no more than 30 days after PAI/US)', 'description': '-Will be used to distinguish between benign and malignant ovarian tissues. Student t-test will be used for statistical significant test of each feature obtained from malignant and benign ovaries. Those features with p value less than 0.05 will be used as a predictor.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Oophorectomy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'The investigators have developed co-registered photoacoustic and ultrasound (US) imaging technique that allows the investigators to visualize tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes in the ovary, using a non-invasive imaging modality will greatly enhance the care for women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Referred to Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy\n* Willingness to participate in the study\n* Able to provide informed consent\n\nExclusion Criteria\n\n* Younger than 18 years of age\n* Not able to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03262818', 'briefTitle': 'Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary', 'orgStudyIdInfo': {'id': '201608016'}, 'secondaryIdInfos': [{'id': '5R01CA151570-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01CA151570-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging', 'description': '* Transvaginal ultrasound (US) prior to surgery\n* Immediately after the transvaginal US, US/PAI imaging will be performed\n* Once the surgeon has removed the ovary(ies) they will be imaged ex vivo. The in vivo and ex vivo US/PAI images will be compared with the final pathologic diagnosis', 'interventionNames': ['Device: Transvaginal ultrasound', 'Device: Ultrasound/Photoacoustic imaging']}], 'interventions': [{'name': 'Transvaginal ultrasound', 'type': 'DEVICE', 'otherNames': ['Transvaginal US'], 'description': '-Will be performed by US technologists at Washington University School of Medicine and read by Dr. Cary Siegel or Dr. Kathryn Robinson', 'armGroupLabels': ['Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging']}, {'name': 'Ultrasound/Photoacoustic imaging', 'type': 'DEVICE', 'otherNames': ['US/PAI'], 'description': '-The light illumination for the photoacoustic imaging system is provided by a wavelength-tunable Ti:Sapphire laser (LOTIS TII), optically pumped by an Nd:YAG laser (LOTIS TII) at 532 nm wavelength.', 'armGroupLabels': ['Transvaginal Ultrasound + Ultrasound/Photoacoustic imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Cary L Siegel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}