Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT06101927
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Molecular Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2023-10-20', 'studyFirstSubmitQcDate': '2023-10-20', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gamma camera-based whole-body [99mTc]Tc-BQ0413 uptake value (%)', 'timeFrame': '24 hours', 'description': 'Whole-body \\[99mTc\\]Tc-BQ0413 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical'}, {'measure': 'SPECT-based [99mTc]Tc-BQ0413 value in tumor lesions (counts)', 'timeFrame': '6 hours', 'description': '\\[99mTc\\]Tc-BQ0413 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts'}, {'measure': 'SPECT-based [99mTc]Tc-BQ0413 uptake value (counts)', 'timeFrame': '6 hours', 'description': 'Focal uptake of \\[99mTc\\]Tc-BQ0413 in the regions without pathological findings will be assessed with SPECT and measured in counts'}, {'measure': 'Tumor-to-background ratio (SPECT)', 'timeFrame': '6 hours', 'description': 'The SPECT-based tumor-to-background ratio will be calculated as follows: the value of \\[99mTc\\]Tc-BQ0413 uptake coinciding with tumor lesions (counts) will be divided by the value of \\[99mTc\\]Tc-BQ0413 uptake coinciding with the regions without pathological findings (counts)'}], 'secondaryOutcomes': [{'measure': 'Percent of cases with abnormal findings relative to baseline [Safety and Tolerability]', 'timeFrame': '24 hours', 'description': 'The safety attributable to \\[99mTc\\]Tc-BQ0413 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (percent of cases with abnormal findings relative to baseline)'}, {'measure': 'Percent of participants with abnormal laboratory values that are related to diagnostic imaging procedure [Safety and Tolerability]', 'timeFrame': '24 hours', 'description': 'The safety attributable to \\[99mTc\\]Tc-BQ0413 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline)'}, {'measure': 'Percent of participants with adverse events that are related to diagnostic imaging procedure [Safety and Tolerability]', 'timeFrame': '24 hours', 'description': 'The safety attributable to \\[99mTc\\]Tc-BQ0413 injections will be evaluated based on the rate of adverse events (percent)'}, {'measure': 'Percent of participants requiring administration of medication due to side effects that are related to diagnostic imaging procedure [Safety and Tolerability]', 'timeFrame': '24 hours', 'description': 'The safety attributable to \\[99mTc\\]Tc-BQ0413 injections will be evaluated based on the rate of administration of concomitant medication (percent)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate-Specific Membrane Antigen', 'Prostate cancer', '[99mTc]Tc-BQ0413', 'SPECT'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The study should evaluate the biological distribution of \\[99mTc\\]Tc-BQ0413 in patients with prostate cancer.\n\nThe primary objective are:\n\n1. To assess the distribution of \\[99mTc\\]Tc- BQ0413 in normal tissues and tumors at different time intervals.\n2. To evaluate dosimetry of \\[99mTc\\]Tc- BQ0413.\n3. To study the safety and tolerability of the drug \\[99mTc\\]Tc- BQ0413 after a single injection in a diagnostic dosage.\n\nThe secondary objective are:\n\n1\\. To compare the obtained \\[99mTc\\]Tc- BQ0413 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in prostate cancer patients.', 'detailedDescription': 'The overall goal is to study the effectiveness of SPECT imaging prostate cancer patients Using technetium-99m labeled BQ0413.\n\nPhase I of the study:\n\nBiodistribution of \\[99mTc\\]Tc-BQ0413 in patients with prostate cancer.\n\nThe main objectives of the study:\n\n1. To evaluate the distribution of \\[99mTc\\]Tc-BQ0413 in normal tissues and tumors in patients with prostate cancer at different time intervals.\n2. To evaluate dosimetry of \\[99mTc\\]Tc-BQ0413 based on the pharmacokinetic parameters of the drug after a single intravenous administration.\n3. To study the safety of use and tolerability of the drug \\[99mTc\\]Tc-BQ0413 after a single intravenous administration in a diagnostic dosage.\n\nAdditional research tasks:\n\n1\\. To conduct a comparative analysis of the diagnostic information obtained in the visualization of prostate cancer by SPECT using \\[99mTc\\]Tc-BQ0413 with data obtained by CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) research of postoperative material.\n\nMethodology:\n\nOpen-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Men', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is \\> 18 years of age\n* Clinical and radiological diagnosis of prostate cancer with histological verification.\n* White blood cell count: \\> 2.0 x 10\\^9/L\n* Haemoglobin: \\> 80 g/L\n* Platelets: \\> 50.0 x 10\\^9/L\n* Bilirubin =\\< 2.0 times Upper Limit of Normal\n* Serum creatinine: Within Normal Limits\n* Blood glucose level not more than 5.9 mmol/L\n* Subject is capable to undergo the diagnostic investigations to be performed in the study\n* Informed consent\n\nExclusion Criteria:\n\n* Active current autoimmune disease or history of autoimmune disease\n* Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)\n* Known HIV positive or chronically active hepatitis B or C\n* Administration of other investigational medicinal product within 30 days of screening\n* Ongoing toxicity \\> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's"}, 'identificationModule': {'nctId': 'NCT06101927', 'briefTitle': 'Molecular Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413', 'organization': {'class': 'OTHER', 'fullName': 'Tomsk National Research Medical Center of the Russian Academy of Sciences'}, 'officialTitle': 'SPECT Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413 ([99mTc]Tc- BQ0413) in Prostate Cancer Patients', 'orgStudyIdInfo': {'id': '[99mTc]Tc- BQ0413'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Prostate cancer 50 mkg', 'description': 'At least five (5) evaluable subjects with prostate cancer with \\[99mTc\\]Tc-BQ0413 (50 mkg)', 'interventionNames': ['Drug: Whole body study and SPECT with [99mTc]Tc-BQ0413']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Prostate cancer 100 mkg', 'description': 'At leaAt least five (5) evaluable subjects with prostate cancer with \\[99mTc\\]Tc-BQ0413 (100 mkg)', 'interventionNames': ['Drug: Whole body study and SPECT with [99mTc]Tc-BQ0413']}], 'interventions': [{'name': 'Whole body study and SPECT with [99mTc]Tc-BQ0413', 'type': 'DRUG', 'otherNames': ['Diagnostic Test:'], 'description': 'One single intravenous injection of \\[99mTc\\]Tc-BQ0413, followed by gamma camera imaging after 2, 4, 6 and 24 hours.', 'armGroupLabels': ['Experimental: Prostate cancer 100 mkg', 'Experimental: Prostate cancer 50 mkg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tomsk', 'country': 'Russia', 'facility': 'TomskNRMC', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}], 'overallOfficials': [{'name': 'Vladimir I Chernov, MD,Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tomsk NRMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tomsk National Research Medical Center of the Russian Academy of Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}