Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Companion to Protocol 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 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Blood Flow (BF) Reduction
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.
From 4 weeks prior to first dose to 8 weeks post treatment
Chaan Ng, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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