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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Pfizer

GlaxoSmithKline

Information provided by (Responsible Party):

Maryellen Sun, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT00749320

First received: September 5, 2008

Last updated: June 16, 2016

Last verified: June 2016

History of Changes

Purpose

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.

Condition	Intervention
Renal Cell Carcinoma	Other: Arterial Spin Labeling Magnetic Resonance Imaging


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
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

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans

Genetic and Rare Diseases Information Center resources: Kidney Cancer Renal Cancer

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	40
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Intervention Details:

ASL MRI performed at different time intervals on participants receiving sunitinib or pazopanib for treating RCC

Other Name: ASL MRI

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749320

Locations


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

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Pfizer

GlaxoSmithKline

Investigators


Principal Investigator:	Maryellen Sun, MD	Beth Israel Deaconess Medical Center

More Information


Responsible Party:	Maryellen Sun, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00749320 History of Changes
Other Study ID Numbers:	08-078
Study First Received:	September 5, 2008
Last Updated:	June 16, 2016
Health Authority:	United States: Institutional Review Board
Individual Participant Data
Plan to Share IPD:	No
Plan Description:	No plan to share IPD

Keywords provided by Dana-Farber Cancer Institute:


MRI Sunitinib Pazopanib

Additional relevant MeSH terms:


Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms	Neoplasms by Site Kidney Diseases Urologic Diseases Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents

ClinicalTrials.gov processed this record on September 23, 2016

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