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. (see Contacts and Locations)
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

September 5, 2008
February 13, 2014
September 2008
September 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • To explore the association of baseline blood flow in renal cell carcinoma measured by ASL MRI and tumor response to treatment with sunitinib [ 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 [ 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 ]
Complete list of historical versions of study NCT00749320 on ClinicalTrials.gov Archive Site
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Arterial Spin Labeling Blood Flow MRI for Evaluation of Response to Antiangiogenic and Targeted Therapies of Renal Cell Carcinoma (RCC)
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.

  • 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.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Renal Cell Carcinoma
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
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
November 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Maryellen Sun, MD 617-754-2559 msun@bidmc.harvard.edu
United States
 
NCT00749320
08-078
Yes
Maryellen Sun, Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Pfizer
  • GlaxoSmithKline
Principal Investigator: Maryellen Sun, MD Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP