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

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Metastatic Renal Cancer

Treatments: Other: Perfusion-CT

Study type: Observational

Funder types: Other

Identifiers

NCT02086734

CTP NK 2012

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

60 participants in 1 patient group

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

Treatment:

Other: Perfusion-CT