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

Not Applicable

Terminated

• Conditions: Renal Cell Carcinoma
• Interventions: Procedure: Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging

• Registration Number: NCT00953446
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Study Start: 2010-06-15
• Primary Completion: 2011-09-13
• Study Completion: 2011-09-13
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging	Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging	* 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

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States