Renal Cell Carcinoma
Conditions
Keywords
metastatic renal cell carcinoma, ASL MRI, sunitinib, AMG386
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 participants are on clinical treatment therapy of sunitinib and AMG386. An MRI is a type of scan that uses powerful magnets to make clearer images or to focus on detailed medical information in the abdomen and pelvis. The imaging done for this study will use the arterial spin labeling (ASL) MRI technique that allows us to see blood flow changes which possibly may indicate changes in tumor growth. Participants will be on a clinical trial for the treatment.
Detailed description
All participants must be enrolled on protocol, Collection of Specimens and Clinical Data from Patients with Renal Cell Carcinoma Treatment with Targeted Therapies, about to start a treatment course with sunitinib and AMG386, and willing to come in for successive MRIs at the following times: baseline, 2 weeks upon initiation of therapy with sunitinib and AMG386, after cycle 2 and/or cycle 4 of therapy, and at the end of your study therapy.
Interventions
PROCEDUREArterial Spin Labeling Blood Flow Magnetic Resonance Imaging
Performed at baseline, 2 weeks upon initiation of therapy, after cycle 2 and/or cycle 4 of therapy, and at the end of treatment
Sponsors
Dana-Farber Cancer Institute
Amgen
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
* Age greater than 18 years * Patients diagnosed with metastatic renal cell carcinoma and who will initiate therapy with the combination of sunitinib and AMG386 as either their first anti-angiogenic therapy or after failure of prior cytokine therapy * Enrolled on protocol 06-105, Collection of specimens and clinical data from patients with renal cell carcinoma treated with targeted therapies * Found to have tumors that are \>/=2.5 cm as determined by CT imaging * Candidate lesions for ASL MRI should be \>/= 2.5cm. Order of preference of lesion location will be as follows: abdominal lesions, bone lesions and chest lesions
Exclusion criteria
* Subjects will be excluded from the study if they have a contraindication to MRI which may include the following: Pacemaker, MRI incompatible metal implant, recently implanted vascular clip, history of claustrophobia, metal fragment within the eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To explore the association of baseline blood flow in renal cell carcinoma(RCC) measured by ASL MRI and tumor response to treatment with the combination of sunitinib and AMG386 | 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 the combination of sunitinib and AMG386 | 2 years |
| To evaluate the association between changes in tumor blood flow on ASL over the course of therapy and at the time of disease progression and resistance to therapy. | 2 years |
| To compare above results to those observed in a comparable patient population receiving sunitinib alone. | 2 years |
Countries
United States
Outcome results
None listed