Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Renal Cell Carcinoma (RCC) Scramble



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/24/2018
Start Date:January 2011
End Date:January 2020

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Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Companion to Protocol 2010-0085

This is a companion protocol to MD Anderson Cancer Center study 2010-0085 (Sequential Therapy
in Advanced Renal Cell Carcinoma Therapy: The "START" Trial).

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 received as part of
study 2010-0085 (either everolimus, bevacizumab, or pazopanib) is working.

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.

Study Procedures:

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 MD Anderson.

Inclusion Criteria:

1. Patient must be enrolled or being considered for enrollment on protocol 2010-0085.

2. Patients must have metastatic renal cell carcinoma (RCC).

3. Age >/= 18 years.

4. Subjects must have adequate renal function as defined by serum creatinine < 1.5x upper
limit of normal.

Exclusion Criteria:

1. Radiotherapy: Subjects may not have received prior radiotherapy to the index lesion
within 4 weeks

2. Female subjects who are pregnant or lactating.

3. Female subjects of childbearing potential (unless they have a negative serum or urine
pregnancy test within 3 days prior to start of study treatment).

4. Allergy to CT contrast media requiring the administration of steroid prophylaxis.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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from
Houston, TX
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