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

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749320
• Other study ID #: 08-078
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Other:
• Arterial Spin Labeling Magnetic Resonance Imaging
ASL MRI performed at different time intervals on participants receiving sunitinib or pazopanib for treating RCC

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Brigham and Women's Hospital, Dana-Farber Cancer Institute, Novartis, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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