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

Metastatic Renal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086734
• Other study ID #: CTP NK 2012
• Status: Completed
• Start date: April 2012
• Est. completion date: July 2018

Study information

• Verified date: September 2018
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Metastatic Renal Cancer
• Neoplasm Metastasis

Intervention

Other:
• Perfusion-CT
Baseline Perfusion CT-Scan (before AAT) Follow-Up I Perfusion-CT Scan 7 days after start with AAT Follow-Up II Perfusion-CT Scan 8 weeks after start with AAT

Locations

Country	Name	City	State
Germany	Urologische Klinik und Poliklinik der Universität München	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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