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

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NCT00749320

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Study Location
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Contraindication to MRI

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Advanced Information
Descriptive Information
Brief Title  ICMJE Arterial Spin Labeling Blood Flow MRI for Evaluation of Response to Antiangiogenic and Targeted Therapies of Renal Cell Carcinoma (RCC)
Official Title  ICMJE Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging for the Evaluation of Response to Antiangiogenic and Targeted Therapies of Metastatic Renal Cell Carcinoma
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE 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
Study Arms  ICMJE ASL MRI
ASL MRI performed at different time intervals on participants receiving sunitnib or pazopanib for treating RCC
Intervention: Other: Arterial Spin Labeling Magnetic Resonance Imaging
Publications * Tsai LL, Bhatt RS, Strob MF, Jegede OA, Sun MRM, Alsop DC, Catalano P, McDermott D, Robson PM, Atkins MB, Pedrosa I. Arterial Spin Labeled Perfusion MRI for the Evaluation of Response to Tyrosine Kinase Inhibition Therapy in Metastatic Renal Cell Carcinoma. Radiology. 2020 Dec 1:201763. doi: 10.1148/radiol.2020201763. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2020)		32
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2008)		40
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00749320
Other Study ID Numbers  ICMJE 08-078
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:No plan to share IPD
Responsible Party Leo Tsai, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE
  • Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Pfizer
  • Novartis
Investigators  ICMJE
Principal Investigator:Leo Tsai, MDBeth Israel Deaconess Medical Center
PRS Account Dana-Farber Cancer Institute
Verification Date February 2020

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