Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients with Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Renal Cell Carcinoma (RCC) Scramble
- Conditions
- Renal Cell Carcinoma
- Interventions
- Procedure: Perfusion CT scan
- Registration Number
- NCT01224288
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DCE-CT Scans Perfusion CT scan DCE-CT = Dynamic contrast enhanced CT - DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.
- Primary Outcome Measures
Name Time Method Tumor Blood Flow (BF) Reduction From 4 weeks prior to first dose to 8 weeks post treatment 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.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) 3 years PFS is calculated from the start of the study until disease progression.
Trial Locations
- Locations (1)
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States