This trial is active, not recruiting.

Condition renal cell carcinoma
Treatment arterial spin labeling magnetic resonance imaging
Sponsor Beth Israel Deaconess Medical Center
Collaborator Dana-Farber Cancer Institute
Start date September 2008
End date February 2018
Trial size 40 participants
Trial identifier NCT00749320, 08-078


The purpose of this study is to assess magnetic resonance imaging (MRI) as a tool to track tumor growth for renal cell carcinoma while the participant is receiving clinical treatment therapy with sunitinib or pazopanib. An MRI is a sophisticated type of scan that uses powerful magnets to make clearer images or to focus on detailed medical information in the participants abdomen and pelvis. This imaging done for this study will use the ASL MRI technique that allows us to see blood flow changes which possibly may indicated tumor growth.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

To explore the association of baseline blood flow in renal cell carcinoma measured by ASL MRI and tumor response to treatment with sunitinib or pazopanib
time frame: 2 years
To explore the association of changes in tumor blood flow that occur early in the course of therapy compared to baseline and response of RCC to treatment with sunitinib or pazopanib
time frame: 2 years
To evaluate the association between canges in tumor blood flow on ASL over the course of therapy and at the time of disease progression and resistance to therapy
time frame: TBD

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients diagnosed with metastatic renal cell carcinoma and who will initiate sunitinib or pazopanib - Enrolled on protocol 06-105, "Collection of specimens and clinical data from patients with renal cell carcinoma treated with targeted therapies," or receiving Pazopanib as part of routine clinical care. - Found to have tumors that are 2.5cm or greater as determined by CT imaging - Candidate lesions for ASL MRI should be 2.5cm or greater. Order of preference of lesion location will be as follows: abdominal lesions, bone lesions and chest lesions Exclusion Criteria: - Contraindication to MRI

Additional Information

Official title Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging for the Evaluation of Response to Antiangiogenic and Targeted Therapies of Metastatic Renal Cell Carcinoma
Principal investigator Leo Tsai, MD
Description - MRI's will be performed at specific time points during the participants treatment for renal cell carcinoma with the drug sunitinib or pazopanib. These ASL MRI's will be performed at baseline, 2 weeks upon initiation of therapy with sunitinib/pazopanib, after cycle 2 and/or cycle 4 of therapy, and at the end of therapy. - The MRI tests for all participants will be done at Beth Israel Deaconess Medical Center.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.