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

Beth Israel Lahey Health

Status: Terminated

Conditions: Renal Cell Carcinoma

Treatments: Procedure: Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00953446

09-105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2 participants in 1 patient group

Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging

Experimental group

Description:

* 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

Treatment:

Procedure: Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging