Back to resultsArterial Spin Labeling Blood Flow MRI for Evaluation of Response to Antiangiogenic and Targeted Therapies of Renal Cell Carcinoma (RCC)
Primary Purpose
Renal Cell Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arterial Spin Labeling Magnetic Resonance Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Cell Carcinoma focused on measuring MRI, Sunitinib, Pazopanib
Eligibility 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
Sites / Locations
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ASL MRI
Arm Description
ASL MRI performed at different time intervals on participants receiving sunitnib or pazopanib for treating RCC
Outcomes
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00749320
First Posted
September 5, 2008
Last Updated
February 24, 2020
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Pfizer, Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00749320
Brief Title
Arterial Spin Labeling Blood Flow MRI for Evaluation of Response to Antiangiogenic and Targeted Therapies of Renal Cell Carcinoma (RCC)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Pfizer, Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
MRI, Sunitinib, Pazopanib
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASL MRI
Arm Type
Other
Arm Description
ASL MRI performed at different time intervals on participants receiving sunitnib or pazopanib for treating RCC
Intervention Type
Other
Intervention Name(s)
Arterial Spin Labeling Magnetic Resonance Imaging
Other Intervention Name(s)
ASL MRI
Intervention Description
ASL MRI performed at different time intervals on participants receiving sunitinib or pazopanib for treating RCC
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo Tsai, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD
Citations:
PubMed Identifier
33258745
Citation
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. 2021 Feb;298(2):332-340. doi: 10.1148/radiol.2020201763. Epub 2020 Dec 1.
Results Reference
derived
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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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