Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma

Completed

• Conditions: Metastatic Renal Cancer
• Interventions: Other: Perfusion-CT

• Registration Number: NCT02086734
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-11-28
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-28
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• no contraindications against contrast-enhanced CT

• obtained 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mRCC patients assessed with Perfusion CT	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

Primary Outcome Measures

Name	Time	Method
Prediction of progression-free interval and overall survival after initialization of antiangiogenic therapy based on baseline values and relative changes of CT perfusion parameters	up to 3 years

Secondary Outcome Measures

Name	Time	Method
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	up to 3 years

Trial Locations

Locations (1)

Urologische Klinik und Poliklinik der Universität München; 🇩🇪 München, Bavaria, Germany