Renal Cell Carcinoma
Conditions
Keywords
MRI, Sunitinib, Pazopanib
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.
Interventions
ASL MRI performed at different time intervals on participants receiving sunitinib or pazopanib for treating RCC
Sponsors
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Pfizer
Novartis
Beth Israel Deaconess Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 2 years |
| 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 | 2 years |
| 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 | 3 years |
Countries
United States
Outcome results
None listed