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

This study is currently recruiting participants.
Verified February 2014 by Dana-Farber Cancer Institute
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: February 13, 2014
Last verified: February 2014
  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:


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: November 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Arterial Spin Labeling Magnetic Resonance Imaging
    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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749320

Contacts
Contact: Maryellen Sun, MD 617-754-2559 msun@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Maryellen Sun, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Toni Choueiri, MD         
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

No publications provided

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: February 13, 2014
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014