Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma
Conditions
Metastatic Renal Cancer
Conditions: official terms
Carcinoma, Renal Cell - Kidney Neoplasms
Conditions: Keywords
Perfusion-CT, mRCC, antiangiogenic therapy, response assessment
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Perfusion-CT
Type: Other
Overall Status
Recruiting
Summary
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.

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

Patients with metastasized renal cell carcinoma treated at the Department of Urology (University of Munich - Grosshadern Campus)

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

and who have given informed consent to participate in the study

Exclusion Criteria:

Patients who have:

- 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
Location
Urologische Klinik und Poliklinik der Universität München
München, Bavaria, Germany
Status: Recruiting
Contact: Jozefina Casuscelli, Dr. med. - +4989/7095-0 - jozefina.casuscelli@med.uni-muenchen.de
Start Date
January 2012
Completion Date
January 2018
Sponsors
Ludwig-Maximilians - University of Munich
Source
Ludwig-Maximilians - University of Munich
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page