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

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ClinicalTrials.gov Identifier: NCT00749320
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : February 26, 2020
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Pfizer
Novartis
Information provided by (Responsible Party):
Leo Tsai, MD, Dana-Farber Cancer Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Other: Arterial Spin Labeling Magnetic Resonance Imaging Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2008
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arms and Interventions
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Arm Intervention/treatment
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 Name: ASL MRI


Outcome Measures
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Primary Outcome Measures :
  1. 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. 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 ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749320


Locations
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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
Novartis
Investigators
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Principal Investigator: Leo Tsai, MD Beth Israel Deaconess Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Leo Tsai, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00749320    
Other Study ID Numbers: 08-078
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD
Keywords provided by Leo Tsai, MD, Dana-Farber Cancer Institute:
MRI
Sunitinib
Pazopanib
Additional relevant MeSH terms:
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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