Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-04 @ 11:31 AM
Study NCT ID:
NCT02086734
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2013-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D003570', 'term': 'Cytidine Triphosphate'}], 'ancestors': [{'id': 'D003597', 'term': 'Cytosine Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-28', 'studyFirstSubmitDate': '2013-11-28', 'studyFirstSubmitQcDate': '2014-03-11', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prediction of progression-free interval and overall survival after initialization of antiangiogenic therapy based on baseline values and relative changes of CT perfusion parameters', 'timeFrame': 'up to 3 years'}], 'secondaryOutcomes': [{'measure': 'Correlation of CT perfusion parameters at baseline as well as their relative changes after start of antiangiogenic therapy with response status according to RECIST 1.1', 'timeFrame': 'up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Perfusion-CT', 'mRCC', 'antiangiogenic therapy', 'response assessment'], 'conditions': ['Metastatic Renal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the evaluation of dynamic contrast-enhanced CT (Perfusion-CT) for therapeutic response predicition in patients with metastasized renal carcinoma (mRCC) undergoing antiangiogenetic therapy (AAT) with multikinase inhibitors.\n\nIn this study patients with mRCC under AAT will be examined with 3 serial Perfusion - CT scans - partially intergrated in their regular staging CT scheme - at baseline (before AAT start), 1 week after AAT as well as 8 weeks after AAT initialization. Thereby selected intrabdomial or intrathoracic metastases will be monitored longitudinally with perfusion CT. Pretreament and post-treament perfusion characteristics of the assessed metastatic lesions will be quantified and correlated with patient outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with metastatic renal cell cancer eligible for AAT (antiangiogenic therapy) with either Sunitinib (Sutent®), Pazopanib (Votrient ®), Sorafenib (Nexavar®) presenting at the Departement of Urology. LMU, meeting the inclusion/exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with metastasized renal cell carcinoma treated at the Department of Urology (University of Munich - Grosshadern Campus)\n\n 1. with either - Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib (Nexavar®) as first-line therapy\n 2. with Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib (Nexavar®) as second-line therapy after failed first-line therapy, who are off therapy for at least 2 weeks\n* no contraindications against contrast-enhanced CT\n* obtained informed consent to participate in the study\n\nExclusion Criteria:\n\nPatients who have:\n\n* not given informed consent\n* known iodine allergy\n* high grade renal insuffiency (eGFR \\< 30ml/min) not on dialysis\n* overt hyperthyreoidism\n* singular metastases \\<1cm in diameter\n* an increase of their baseline creatine levels of \\>20% between CT examinations'}, 'identificationModule': {'nctId': 'NCT02086734', 'briefTitle': 'Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'CTP NK 2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mRCC patients assessed with Perfusion CT', 'description': 'Study population consists of patients with metastasized renal cancer eligible for AAT with either Sunitinib (Sutent®), Pazopanib (Votrient ®), Sorafenib (Nexavar®) evaluated with Perfusion-CT', 'interventionNames': ['Other: Perfusion-CT']}], 'interventions': [{'name': 'Perfusion-CT', 'type': 'OTHER', 'description': '1. Baseline Perfusion CT-Scan (before AAT)\n2. Follow-Up I Perfusion-CT Scan 7 days after start with AAT\n3. Follow-Up II Perfusion-CT Scan 8 weeks after start with AAT', 'armGroupLabels': ['mRCC patients assessed with Perfusion CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Urologische Klinik und Poliklinik der Universität München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}], 'overallOfficials': [{'name': 'Michael Staehler, Prof. Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Urologische Klinik und Poliklinik der Universität München'}, {'name': 'Anno Graser, Prof. Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut für Klinische Radiologie des Klinikums der Universität München'}, {'name': 'Alexander Sterzik, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut für Klinische Radiologie des Klinikums der Universität München'}, {'name': 'Jozefina Casuscelli, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urologische Klinik und Poliklinik der Universität München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Dr. Jozefina Casuscelli', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}