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 |
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.
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.
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
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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