Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging for the Evaluation of Response to Therapy in Metastatic Renal Cell Carcinoma

Study Overview
=================
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.

Official Title
-----------------
Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging for the Evaluation of the Response to Therapy With the Combination of Sunitinib and AMG386 in Metastatic Renal Cell Carcinoma

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Procedure: Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging<br>ASL MRI Performed at baseline, 2 weeks upon initiation of therapy, after cycle 2 and/or cycle 4 of therapy, and at the end of treatment | Procedure: Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging<br>* Performed at baseline, 2 weeks upon initiation of therapy, after cycle 2 and/or cycle 4 of therapy, and at the end of treatment<br>* Other names: ASL MRI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic renal cell carcinoma, ASL MRI, sunitinib, AMG386