Arterial Spin Labeling Blood Flow MRI for Evaluation of Response to Antiangiogenic and Targeted Therapies of Renal Cell Carcinoma (RCC)

Not Applicable

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Other: Arterial Spin Labeling Magnetic Resonance Imaging

• Registration Number: NCT00749320
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ASL MRI	Arterial Spin Labeling Magnetic Resonance Imaging	ASL MRI performed at different time intervals on participants receiving sunitnib or pazopanib for treating RCC

Primary Outcome Measures

Name	Time	Method
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	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	3 years
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	2 years

Trial Locations

Locations (2)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States