Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 10:17 AM
Study NCT ID:
NCT00831857
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2009-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VEGF Imaging in Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], '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': 'D007680', 'term': 'Kidney 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2009-01-28', 'studyFirstSubmitQcDate': '2009-01-28', 'lastUpdatePostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the change in SUV between baseline 89Zr-bevacizumab PET scan and the scan performed after 2 and 6 weeks of treatment with sunitinib or bevacizumab plus interferon in patients with RCC.', 'timeFrame': 'after 2 and 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progression is defined as the appearance of new disease or an increase of 20% in the sum of the longest diameters of the target lesions.', 'timeFrame': '3 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the feasibility of 89Zr-bevacizumab PET imaging as a biomarker before and during treatment with sunitinib or bevacizumab plus interferon in patients with RCC. 89Zr-bevacizumab PET imaging will be regarded a promising biomarker if the target for treatment (VEGF) can be visualised and if uptake changes after institution of treatment.', 'detailedDescription': '* To explore if 89Zr-bevacizumab PET imaging can differentiate RCC patients with progressive disease from patients with non-progressive disease during treatment with sunitinib or bevacizumab plus interferon.\n* To explore relationships between VEGF pathway related biomarkers and 89Zr-bevacizumab PET response.\n* To explore effect of 2 weeks off treatment in the sunitinib arm on pharmacodynamic biomarkers and 89Zr-bevacizumab PET response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients locally advanced irresectable or metastatic renal cell cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* locally advanced irresectable or metastatic renal cell cancer\n* no untreated brain metastases (CT or MRI not necessary in the absence of symptoms)\n* no uncontrolled hypertension\n* no clinically significant cardiovascular events or disease during the last 12 months\n* no surgery in the last 4 weeks\n* no treatment with bevacizumab or another monoclonal antibody with anti-angiogenic properties in the last 4 months\n* no treatment with a tyrosine kinase inhibitor during the last 4 weeks\n* measurable disease with x-ray or CT scan, at least one site of disease must be unidimensionally measurable as follows: X-ray \\> 20 mm, Spiral CT scan \\> 10 mm, non-spiral CT scan \\> 20 mm\n* clear cell histology component\n* not pregnant or nursing\n* women of childbearing potential must use effective contraception\n* absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n* before patient randomization, written informed consent must be given according to GCP, and local regulations'}, 'identificationModule': {'nctId': 'NCT00831857', 'acronym': 'Renimage', 'briefTitle': 'VEGF Imaging in Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': '89Zr-bevacizumab PET Imaging in Patients With Renal Cell Carcinoma Treated With Sunitinib or Bevacizumab Plus Interferon; a Pilot Study', 'orgStudyIdInfo': {'id': 'Renimage Protocol'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Treatment with sunitinib.', 'interventionNames': ['Other: 89Zr-Bevacizumab PET-scan']}, {'label': 'Group B', 'description': 'Treatment with bevacizumab and interferon', 'interventionNames': ['Other: 89Zr-Bevacizumab PET-scan']}], 'interventions': [{'name': '89Zr-Bevacizumab PET-scan', 'type': 'OTHER', 'description': 'At baseline, after two weeks of treatment and after 6 weeks of treatment.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700 RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Sjoukje F. Oosting, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}