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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Procedure: Perfusion CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be enrolled or being considered for enrollment on protocol 2010-0085. Patients must have metastatic renal cell carcinoma (RCC). Age >/= 18 years. Subjects must have adequate renal function as defined by serum creatinine < 1.5x upper limit of normal. Exclusion Criteria: Radiotherapy: Subjects may not have received prior radiotherapy to the index lesion within 4 weeks Female subjects who are pregnant or lactating. Female subjects of childbearing potential (unless they have a negative serum or urine pregnancy test within 3 days prior to start of study treatment). Allergy to CT contrast media requiring the administration of steroid prophylaxis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCE-CT Scans<br>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<br>* DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor 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. Tumor BF of index lesions computed using commercially available software (GE CT perfusion) using the same index lesion assessed on follow-up scans. | From 4 weeks prior to first dose to 8 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | PFS is calculated from the start of the study until disease progression. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCC, Kidney cancer, mRCC, Metastatic renal cell carcinoma, Dynamic contrast enhanced CT, DCE-CT, Tumor perfusion