Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-20 @ 6:03 PM
Study NCT ID:
NCT00509704
Status:
COMPLETED
Last Update Posted:
2010-11-09
First Post:
2007-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Sutent on Tumor Vascularization and Necrosis in Patients With 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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-08', 'studyFirstSubmitDate': '2007-07-30', 'studyFirstSubmitQcDate': '2007-07-30', 'lastUpdatePostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-31', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sutent', 'tumor necrosis', 'DCE-MRI (Dynamic enhanced magnetic resonance imaging)'], 'conditions': ['Renal Cell Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the effect of Sunitinib on tumor vascularization and necrosis in patients with metastatic renal cell cancer.', 'detailedDescription': 'Sutent is an angiogenesis inhibitor used in the treatment of renal cell cancer. Very often tumor necrosis is seen after the start of the treatment. It is unknown after how many days this effect starts. In patients with renal cell cancer with metastases, who will be treated with Sutent, 3 MRIs will be made. Kep, R2\\*, b-coefficient (perfusion, hypoxia, blood volume and necrosis) will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a malignant abdominal tumor or metastases (minimal diameter 2 cm)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with metastatic renal cell cancer for whom treatment with Sunitinib is planned\n* histologically verified stage IV renal cell carcinoma of clear cell type\n* measurable primary tumor or metastases (minimal diameter 2 cm) at other sites than the lungs\n* Karnofsky score \\> 70%\n* age \\> 18 year.\n* written informed consent\n\nExclusion Criteria:\n\n* contra-indications for MRI\n* contra-indications for treatment with Sunitinib\n* previous systemic treatment within the last 30 days'}, 'identificationModule': {'nctId': 'NCT00509704', 'briefTitle': 'Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Pilot Study on the Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'CMO 2006/232'}}, 'contactsLocationsModule': {'locations': [{'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'UMC St Radboud', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'C.M.L. van Herpen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC St Radboud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'C.M.L. van Herpen,', 'oldOrganization': 'University Medical Centre Nijmegen, st Radboud'}}}}