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

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00953446
• Other study ID #: 09-105
• Status: Terminated
• Phase: N/A
• Start date: June 15, 2010
• Est. completion date: September 13, 2011

Study information

• Verified date: June 2020
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 13, 2011
• Est. primary completion date: September 13, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Procedure:
• Arterial 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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Amgen, Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	To compare above results to those observed in a comparable patient population receiving sunitinib alone.		2 years