Renal Cell Carcinoma (RCC) Scramble
The goal of this clinical research study is to learn if dynamic contrast enhanced computed tomography (DCE-CT) scans can help researchers learn if the study drug you receive as part of study 2010-0085 (either everolimus, bevacizumab, or pazopanib) is working.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Companion to Protocol 2010-0085|
- Blood Flow (BF) Reduction [ Time Frame: From 4 weeks prior to first dose to 8 weeks post treatment ] [ Designated as safety issue: No ]Changes in perfusion parameters assessed at first re-staging (approximately 8 weeks) and shortly after initiating therapy (2 - 7 days), for three different therapies using organ-directed DCE-CT tumor assessments.
- Progression Free Survival (PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]PFS is calculated from the start of the study until disease progression.
|Study Start Date:||January 2011|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: DCE-CT Scans
DCE-CT = Dynamic contrast enhanced CT - DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.
Procedure: Perfusion CT scan
DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.
To perform a DCE-CT scan, a small amount of a special dye (called "CT contrast medium") is injected by vein into the body. Several CT images are then taken over a few minutes to learn how much dye spreads outside of the tumor. This can show how much blood flows to and from the tumor. By performing DCE-CT scans after several weeks on treatment, researchers may learn if changes in blood flow may be a sign that the treatment is working.
If you are found to be eligible to take part in this study, you will have a DCE-CT scan to check the status of the disease at the following times:
- Within about 4 weeks before you begin treatment on study 2010-0085.
- Eight (8) weeks after starting treatment on study 2010-0085.
Before each of the DCE-CT scans are performed, blood (about 1 tablespoon) will be drawn to check your kidney function.
If your doctor thinks it is needed, you will also have a standard-of-care CT scan at these timepoints to check the status of the disease.
Length of Study:
Your participation in this study will be over after the scan(s) 8 weeks after starting treatment on study 2010-0085. You will be taken off of this study if you leave the 2010-0085 study early.
This is an investigational study. The DCE-CT scan is commercially available. Using DCE-CT scans to check the status of kidney cancer is investigational.
Up to 120 patients will take part in this study. All will be enrolled at M. D. Anderson.
|Contact: Chaan Ng, MD||713-792-6759|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Chaan Ng, MD|
|Principal Investigator:||Chaan Ng, MD||UT MD Anderson Cancer Center|