Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma
NCT ID: NCT02086734
Last Updated: 2018-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2012-04-30
2018-07-31
Brief Summary
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In 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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mRCC patients assessed with Perfusion CT
Study population consists of patients with metastasized renal cancer eligible for AAT with either Sunitinib (Sutent®), Pazopanib (Votrient ®), Sorafenib (Nexavar®) evaluated with Perfusion-CT
Perfusion-CT
1. Baseline Perfusion CT-Scan (before AAT)
2. Follow-Up I Perfusion-CT Scan 7 days after start with AAT
3. Follow-Up II Perfusion-CT Scan 8 weeks after start with AAT
Interventions
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Perfusion-CT
1. Baseline Perfusion CT-Scan (before AAT)
2. Follow-Up I Perfusion-CT Scan 7 days after start with AAT
3. Follow-Up II Perfusion-CT Scan 8 weeks after start with AAT
Eligibility Criteria
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Inclusion Criteria
1. with either - Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib (Nexavar®) as first-line therapy
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
* no contraindications against contrast-enhanced CT
* obtained informed consent to participate in the study
Exclusion Criteria
* not given informed consent
* known iodine allergy
* high grade renal insuffiency (eGFR \< 30ml/min) not on dialysis
* overt hyperthyreoidism
* singular metastases \<1cm in diameter
* an increase of their baseline creatine levels of \>20% between CT examinations
18 Years
ALL
No
Sponsors
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Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Dr. Jozefina Casuscelli
Dr. med.
Principal Investigators
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Michael Staehler, Prof. Dr. med.
Role: STUDY_CHAIR
Urologische Klinik und Poliklinik der Universität München
Anno Graser, Prof. Dr. med.
Role: STUDY_DIRECTOR
Institut für Klinische Radiologie des Klinikums der Universität München
Alexander Sterzik, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Institut für Klinische Radiologie des Klinikums der Universität München
Jozefina Casuscelli, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Urologische Klinik und Poliklinik der Universität München
Locations
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Urologische Klinik und Poliklinik der Universität München
München, Bavaria, Germany
Countries
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Other Identifiers
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CTP NK 2012
Identifier Type: -
Identifier Source: org_study_id
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