Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT01762592
Status:
WITHDRAWN
Last Update Posted:
2017-12-22
First Post:
2012-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007455', 'term': 'Iodine'}, {'id': 'C106533', 'term': 'G250 monoclonal antibody'}], 'ancestors': [{'id': 'D006219', 'term': 'Halogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'new sponsor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-20', 'studyFirstSubmitDate': '2012-12-19', 'studyFirstSubmitQcDate': '2013-01-04', 'lastUpdatePostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of Iodine (124I) Girentuximab PET/CT scans will be compared to the threshold value of 0.70 using a two-sided exact binomial test at level 0.05.', 'timeFrame': 'PET/CT imaging of the kidneys will be performed 5 (±1) days (Day 4, 5, or 6) after the Iodine (124I) Girentuximab infusion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma', 'Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'Study WX-20-002 will confirm diagnostic efficacy and safety of a PET/CT scan using Iodine (124I) Girentuximab performed during the diagnostic work-up in patients with indeterminate cT1-renal masses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ≥18 years of age.\n2. Presence of indeterminate cT1 renal mass by screening CT with and without contrast or MRI with and without contrast (MRI only if CT is contra-indicated).\n3. Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product.\n4. Recovered from toxicity of any prior therapy to grade 1 or better.\n5. Able to take oral medication (KI).\n6. Written informed consent available.\n\nExclusion Criteria:\n\n1. Renal mass known to be a metastasis of another primary tumor.\n2. Known histology of renal mass (e.g. by biopsy).\n3. Active non-renal malignancy requiring therapy during the time frame of individual patient study participation.\n4. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to Iodine (124I) Girentuximab infusion on Day 0 or continuing adverse effects (\\>grade 1) from such therapy.\n5. Exposure to murine proteins or chimeric antibodies within the last 5 years.\n6. Intercurrent medical condition that may limit patient's study participation or compliance.\n7. History of autoimmune hepatitis.\n8. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.\n9. Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrollment.\n10. Women who are pregnant or breastfeeding.\n11. Contraindication to KI intake (see package insert/Appendix VI).\n12. Hyperthyroidism, or Grave's Disease.\n13. Contraindication for PET/CT."}, 'identificationModule': {'nctId': 'NCT01762592', 'briefTitle': 'REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heidelberg Pharma AG'}, 'officialTitle': 'A Study of Iodine (124I) Girentuximab PET/CT Scan for the Detection of Clear Cell Renal Cell Carcinoma in Patients With Indeterminate cT1 Renal Masses', 'orgStudyIdInfo': {'id': 'WX/20-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iodine (124I) Girentuximab', 'description': 'Single infusion of radio labeled antibody: 30 mL will be infused using an infusion pump at a rate of 2mL/min over 15 minutes on study day 0.', 'interventionNames': ['Drug: Iodine (124I) Girentuximab']}], 'interventions': [{'name': 'Iodine (124I) Girentuximab', 'type': 'DRUG', 'otherNames': ['124I-cG250'], 'description': 'i.v.', 'armGroupLabels': ['Iodine (124I) Girentuximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1721', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicine, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center & Research Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27711', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104-4283', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg Pharma AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}