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NCT Number: NCT01224288

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

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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perfusion CT scan

Procedure

DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.

Primary outcomes

  1. Tumor Blood Flow (BF) Reduction

    Time frame: 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 outcomes

  1. Progression Free Survival (PFS)

    Time frame: 3 years

    PFS is calculated from the start of the study until disease progression.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2029
Study completion
2029
First posted
Oct 20, 2010
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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