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:
Beth Israel Deaconess Medical Center
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Renal Cell Carcinoma |
Procedure: Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953446
Locations
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Amgen
Investigators
| Principal Investigator: | Ivan Pedrosa, MD | Beth Israel Deaconess Medical Center |
More Information
No publications provided
| Responsible Party: | Ivan Pedrosa, MD, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00953446 History of Changes |
| Other Study ID Numbers: | 09-105 |
| Study First Received: | August 5, 2009 |
| Last Updated: | November 18, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
metastatic renal cell carcinoma ASL MRI sunitinib AMG386 |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013