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

This study has suspended participant recruitment.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Amgen
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00953446
First received: August 5, 2009
Last updated: November 18, 2010
Last verified: November 2010
History of Changes

August 5, 2009
November 18, 2010
August 2009
August 2011   (final data collection date for primary 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To compare above results to those observed in a comparable patient population receiving sunitinib alone. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00953446 on ClinicalTrials.gov Archive Site
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Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging for the Evaluation of Response to Therapy in Metastatic Renal Cell Carcinoma
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

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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Renal Cell Carcinoma
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
Other Name: ASL MRI
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
20
Not Provided
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00953446
09-105
Yes
Ivan Pedrosa, MD, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Amgen
Principal Investigator: Ivan Pedrosa, MD Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP