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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


N/A
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Ivan Pedrosa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Institutional Review Board

Study ID:

09-105

NCT ID:

NCT00953446

Start Date:

August 2009

Completion Date:

Related Keywords:

  • Renal Cell Carcinoma
  • metastatic renal cell carcinoma
  • ASL MRI
  • sunitinib
  • AMG386
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115