Arterial Spin Labeling Blood Flow MRI for Evaluation of Response to Antiangiogenic and Targeted Therapies of Renal Cell Carcinoma (RCC)
NCT00749320
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- 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
- Contraindication to MRI
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Descriptive Information | |||||
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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 |
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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 | 32 | ||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Responsible Party | Leo Tsai, MD, Dana-Farber Cancer Institute | ||||
Study Sponsor ICMJE | Beth Israel Deaconess Medical Center | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |