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

NCT ID: NCT01224288

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-05

Study Completion Date

2029-04-30

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.

Conditions

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Renal Cell Carcinoma

Keywords

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RCC Kidney cancer Metastatic renal cell carcinoma mRCC Dynamic contrast enhanced CT DCE-CT Tumor perfusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DCE-CT Scans

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

Group Type EXPERIMENTAL

Perfusion CT scan

Intervention Type PROCEDURE

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

Interventions

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Perfusion CT scan

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chaan Ng, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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NCI-2011-03288

Identifier Type: REGISTRY

Identifier Source: secondary_id

2009-0845

Identifier Type: -

Identifier Source: org_study_id