Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT04857502
Status:
RECRUITING
Last Update Posted:
2025-07-15
First Post:
2021-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}, {'id': 'D017785', 'term': 'Photons'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D004601', 'term': 'Elementary Particles'}, {'id': 'D008027', 'term': 'Light'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2021-04-20', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The biodistribution of 99mTc-PSMA-I&S in normal and malignant tissues of patients with prostate cancer will be measured by average and maximum standardized uptake value (SUVmean and SUVmax)', 'timeFrame': 'time from injection to imaging (range: 1-46 hours)'}], 'secondaryOutcomes': [{'measure': '99mTc-PSMA-I&S accumulation within tumor lesions observed by in-vivo SPECT (SUVmean and SUVmax) will be correlated with ex-vivo gamma measurements (counts/minute) and level of PSMA expression quantified by histopathology (IHC score)', 'timeFrame': 'time from injection to imaging (range: 1-46 hours)'}, {'measure': 'The best time-point for 99mTc-PSMA-I&S radioguided surgery will be determined by the tumor-to-background uptake ratio (TBR) using the time-activity curve function', 'timeFrame': 'time from injection to imaging (range: 1-46 hours)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Carcinoma', 'Recurrent Prostate Carcinoma']}, 'descriptionModule': {'briefSummary': 'This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I\\&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I\\&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc). Giving 99mTc-PSMA-I\\&S may detect PSMA-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To define the biodistribution of 99mTc-based PSMA imaging and surgery agent (99mTc-PSMA-I\\&S) in normal and malignant tissues of patients with prostate cancer (PCa) with histopathology validation, when available.\n\nSECONDARY OBJECTIVES:\n\nI. To correlate the 99mTc-PSMA-I\\&S accumulation within tumor lesions observed by in-vivo single-photon emission computed tomography (SPECT), ex-vivo gamma measurements and level of prostate-specific membrane antigen (PSMA) expression quantified by histopathology, when available.\n\nII. To define the best time-point for radio-guided surgery (RGS) with the highest tumor-to-background ratio following 99mTc-PSMA-I\\&S administration.\n\nOUTLINE:\n\nThe first 5 patients receive an initial dose of 99mTc-PSMA-I\\&S intravenously (IV) followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I\\&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I\\&S IV before surgery.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men with PCa (primary or recurrent disease)\n* Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging\n* Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT\n* Men who are scheduled for pelvic LN dissection (PLND)\n* Men who can provide oral and written informed consent\n* Men who can comply with study procedures\n\nExclusion Criteria:\n\n* Patients who started any PCa treatment between study enrollment and surgery\n* Technically inaccessible nodal location'}, 'identificationModule': {'nctId': 'NCT04857502', 'briefTitle': '99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': '99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation', 'orgStudyIdInfo': {'id': '20-002256'}, 'secondaryIdInfos': [{'id': 'NCI-2021-01793', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (99mTc-PSMA-I&S, SPECT/CT)', 'description': 'The first 5 patients receive an initial dose of undergo 99mTc-PSMA-I\\&S IV followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I\\&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I\\&S IV before standard of care surgery.', 'interventionNames': ['Drug: 99mTc-based PSMA Imaging and Surgery Agent', 'Procedure: Computed Tomography', 'Procedure: Single Photon Emission Computed Tomography']}], 'interventions': [{'name': '99mTc-based PSMA Imaging and Surgery Agent', 'type': 'DRUG', 'description': 'Given via IV injection', 'armGroupLabels': ['Diagnostic (99mTc-PSMA-I&S, SPECT/CT)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computerized Axial Tomography', 'Computerized Tomography', 'CT', 'CT Scan', 'tomography'], 'description': 'Undergo SPECT/CT', 'armGroupLabels': ['Diagnostic (99mTc-PSMA-I&S, SPECT/CT)']}, {'name': 'Single Photon Emission Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Single Photon Emission Computed Tomography', 'Single Photon Emission Tomography', 'single-photon emission computed tomography', 'SPECT', 'SPECT imaging', 'SPECT SCAN', 'SPET', 'tomography, emission computed, single photon', 'Tomography, Emission-Computed, Single-Photon'], 'description': 'Undergo SPECT/CT', 'armGroupLabels': ['Diagnostic (99mTc-PSMA-I&S, SPECT/CT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deepu Varughese', 'role': 'CONTACT', 'email': 'DVarughese@mednet.ucla.edu', 'phone': '310-206-7372'}, {'name': 'Ankush Sachdeva', 'role': 'CONTACT', 'email': 'ASachdeva@mednet.ucla.edu', 'phone': '310-794-3421'}, {'name': 'Jeremie Calais, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCLA / Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Deepu Varughese', 'role': 'CONTACT', 'email': 'DVarughese@mednet.ucla.edu', 'phone': '310-206-7372'}, {'name': 'Ankush Sachdeva', 'role': 'CONTACT', 'email': 'ASachdeva@mednet.ucla.edu', 'phone': '310-794-3421'}], 'overallOfficials': [{'name': 'Jeremie Calais, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA / Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}