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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

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Trial Information

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.

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 60 patients will take part in this study. All will be enrolled at M. D. 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Blood Flow (BF) Reduction

Outcome Description:

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.

Outcome Time Frame:

From 4 weeks prior to first dose to 8 weeks post treatment

Safety Issue:

No

Principal Investigator

Chaan Ng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2009-0845

NCT ID:

NCT01224288

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Renal Cell Carcinoma
  • RCC
  • Kidney cancer
  • Metastatic renal cell carcinoma
  • mRCC
  • Dynamic contrast enhanced CT
  • DCE-CT
  • Tumor perfusion
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030