Back to resultsArterial Spin Labeling Blood Flow Magnetic Resonance Imaging for the Evaluation of Response to Therapy in Metastatic Renal Cell Carcinoma
Primary Purpose
Renal Cell Carcinoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Cell Carcinoma focused on measuring metastatic renal cell carcinoma, ASL MRI, sunitinib, AMG386
Eligibility 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
Sites / Locations
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging
Arm 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
Outcomes
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
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
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.
To compare above results to those observed in a comparable patient population receiving sunitinib alone.
Secondary Outcome Measures
Full Information
NCT ID
NCT00953446
First Posted
August 5, 2009
Last Updated
June 26, 2020
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dana-Farber Cancer Institute, Amgen
1. Study Identification
Unique Protocol Identification Number
NCT00953446
Brief Title
Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging for the Evaluation of Response to Therapy in Metastatic Renal Cell Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Study Start Date
June 15, 2010 (Actual)
Primary Completion Date
September 13, 2011 (Actual)
Study Completion Date
September 13, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Dana-Farber Cancer Institute, Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
metastatic renal cell carcinoma, ASL MRI, sunitinib, AMG386
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging
Other Intervention Name(s)
ASL MRI
Intervention Description
Performed at baseline, 2 weeks upon initiation of therapy, after cycle 2 and/or cycle 4 of therapy, and at the end of treatment
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
To compare above results to those observed in a comparable patient population receiving sunitinib alone.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Pedrosa, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging for the Evaluation of Response to Therapy in Metastatic Renal Cell Carcinoma
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