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

February 24, 2020 updated by: Leo Tsai, MD, Beth Israel Deaconess Medical Center

Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging for the Evaluation of Response to Antiangiogenic and Targeted Therapies of Metastatic Renal Cell Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ASL MRI
ASL MRI performed at different time intervals on participants receiving sunitnib or pazopanib for treating RCC
Other: Arterial Spin Labeling Magnetic Resonance Imaging
ASL MRI performed at different time intervals on participants receiving sunitinib or pazopanib for treating RCC
Other Names:
  • ASL MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Novartis
Pfizer
Dana-Farber Cancer Institute
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Leo Tsai, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share IPD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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