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11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT01917136
Recruitment Status : Completed
First Posted : August 6, 2013
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
Brigham and Women's Hospital
University of Maryland
Yale University
Washington University School of Medicine
The Cardiovascular Medical Research and Education Fund
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Pulmonary Hypertension
Interventions Drug: 11C-acetate
Drug: [18F]Fluoro-2-deoxy-2-D-glucose
Other: Cardiac MRI
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 11c-acetate and 18F-FDG, and Cardiac MRI
Hide Arm/Group 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.

11C-acetate: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate

[18F]Fluoro-2-deoxy-2-D-glucose: For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG

Cardiac MRI: Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.

Period Title: Overall Study
Started 21
Completed 21
Not Completed 0
Arm/Group Title 11c-acetate and 18F-FDG, and Cardiac MRI
Hide Arm/Group 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.

11C-acetate: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate

[18F]Fluoro-2-deoxy-2-D-glucose: For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG

Cardiac MRI: Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.

Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
54.4  (15.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
13
  61.9%
Male
8
  38.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Changes in RV Function
Hide Description RV function as measured by cardiac MRI
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patient completed the cardiac MRI at 6 months, changes in RVEF
Arm/Group Title 11c-acetate and 18F-FDG, and Cardiac MRI
Hide Arm/Group 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.

11C-acetate: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate

[18F]Fluoro-2-deoxy-2-D-glucose: For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG

Cardiac MRI: Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.

Overall Number of Participants Analyzed 21
Least Squares Mean (Standard Error)
Unit of Measure: percentage
7.56  (1.72)
Time Frame 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 11c-acetate and 18F-FDG, and Cardiac MRI
Hide Arm/Group 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.

11C-acetate: For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate

[18F]Fluoro-2-deoxy-2-D-glucose: For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG

Cardiac MRI: Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.

All-Cause Mortality
11c-acetate and 18F-FDG, and Cardiac MRI
Affected / at Risk (%)
Total   0/21 (0.00%) 
Hide Serious Adverse Events
11c-acetate and 18F-FDG, and Cardiac MRI
Affected / at Risk (%)
Total   0/21 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
11c-acetate and 18F-FDG, and Cardiac MRI
Affected / at Risk (%)
Total   0/21 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Yuchi Han
Organization: University of Pennsylvania
Phone: 215-662-2855
EMail: yuchi.han@uphs.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01917136    
Obsolete Identifiers: NCT01953965
Other Study ID Numbers: 817786
First Submitted: August 3, 2013
First Posted: August 6, 2013
Results First Submitted: November 30, 2018
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019