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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02086734

Enrollment

Registered

2014-03-13

Start date

2012-04-30

Completion date

2018-07-31

Last updated

2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Renal Cancer

Keywords

Perfusion-CT, mRCC, antiangiogenic therapy, response assessment

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.

Interventions

OTHERPerfusion-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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026