Arterial Spin Labeling Blood Flow MRI for Evaluation of Response to Antiangiogenic and Targeted Therapies of Renal Cell Carcinoma (RCC)
This study is ongoing, but not recruiting participants.
Sponsor:
Beth Israel Deaconess Medical Center
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: September 9, 2014
Last verified: September 2014
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Purpose
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 | Intervention |
|---|---|
|
Renal Cell Carcinoma |
Other: Arterial Spin Labeling Magnetic Resonance Imaging |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
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 [ 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749320
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749320
Locations
| 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
GlaxoSmithKline
Investigators
| Principal Investigator: | Maryellen Sun, MD | Beth Israel Deaconess Medical Center |
More Information
No publications provided
| Responsible Party: | Maryellen Sun, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00749320 History of Changes |
| Other Study ID Numbers: | 08-078 |
| Study First Received: | September 5, 2008 |
| Last Updated: | September 9, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
MRI Sunitinib Pazopanib |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Adenocarcinoma Carcinoma Kidney Diseases Kidney Neoplasms Neoplasms |
Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Neoplasms Urologic Diseases Urologic Neoplasms |
ClinicalTrials.gov processed this record on March 03, 2015