Back to results11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
11C-acetate
[18F]Fluoro-2-deoxy-2-D-glucose
Cardiac MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Hypertension focused on measuring pulmonary hypertension, right ventricular function, 11C acetate, FDG, ranolazine
Eligibility Criteria
Inclusion Criteria:
Participation in the companion treatment protocol "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction"
Exclusion Criteria:
- Pregnancy or lactation: Women of childbearing potential must have a negative urine or blood pregnancy test on the day of the PET/CT scan.
- Severe anxiety or claustrophobia prohibiting completion of imaging
- Inability to tolerate imaging procedures (1 hour MRI, 30 min and 15 min PET)
- Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any other contraindication to MRI.
- Uncontrolled diabetes mellitus with fasting glucose > 150 mg/dL
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
11c-acetate and 18F-FDG, and cardiac MRI
Arm Description
For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed.
Outcomes
Primary Outcome Measures
Changes in RV Function
RV function as measured by cardiac MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT01917136
First Posted
August 3, 2013
Last Updated
January 14, 2019
Sponsor
University of Pennsylvania
Collaborators
Brigham and Women's Hospital, University of Maryland, Yale University, Washington University School of Medicine, The Cardiovascular Medical Research and Education Fund
1. Study Identification
Unique Protocol Identification Number
NCT01917136
Brief Title
11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension
Official Title
Evaluation of Regional Myocardial Perfusion, Glucose Utilization and Oxidative Metabolism in Patients With Pulmonary Hypertension Using Combined [11C]Acetate and [18F]Fluorodeoxyglucose (FDG) PET/CT and Cardiovascular MRI
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Brigham and Women's Hospital, University of Maryland, Yale University, Washington University School of Medicine, The Cardiovascular Medical Research and Education Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is looking at differences in metabolism and functional imaging between pulmonary hypertension subjects with normal right ventricular function and persistent right ventricular dysfunction.
Detailed Description
We will measure right ventricular metabolic and structural changes using serial 11C-acetate and 18F-FDG PET/CT and cardiac MRI as response to treatment with ranolazine. Subjects undergo imaging procedures at week 0 and week 26 (optional for normal function patients). This is a companion imaging trial for patients who are eligible for the treatment trial entitled "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction". Subjects must enroll in companion treatment protocol to qualify for the imaging protocol.
The cardiac MRI portion of the study continued, but the PET portion of the study was discontinued due to funding.
The treatment protocol is registered under: NCT01839110. Due to funding issues, the completed study was registered under NCT02829034.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
pulmonary hypertension, right ventricular function, 11C acetate, FDG, ranolazine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
11c-acetate and 18F-FDG, and cardiac MRI
Arm Type
Experimental
Arm Description
For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate and a 10 millicurie injection of 18F-FDG At baseline/6 months follow up, a cardiac MRI will be performed.
Intervention Type
Drug
Intervention Name(s)
11C-acetate
Intervention Description
For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate
Intervention Type
Drug
Intervention Name(s)
[18F]Fluoro-2-deoxy-2-D-glucose
Other Intervention Name(s)
18F-FDG
Intervention Description
For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG
Intervention Type
Other
Intervention Name(s)
Cardiac MRI
Intervention Description
Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.
Primary Outcome Measure Information:
Title
Changes in RV Function
Description
RV function as measured by cardiac MRI
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participation in the companion treatment protocol "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction"
Exclusion Criteria:
Pregnancy or lactation: Women of childbearing potential must have a negative urine or blood pregnancy test on the day of the PET/CT scan.
Severe anxiety or claustrophobia prohibiting completion of imaging
Inability to tolerate imaging procedures (1 hour MRI, 30 min and 15 min PET)
Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any other contraindication to MRI.
Uncontrolled diabetes mellitus with fasting glucose > 150 mg/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuchi Han, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data available upon request
Learn more about this trial
11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension
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