Trial Outcomes & Findings for 11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension (NCT NCT01917136)

Results Overview

RV function as measured by cardiac MRI

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

6 months

Results posted on

2019-02-05

Participant milestones
Measure	11c-acetate and 18F-FDG, and Cardiac MRI 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 Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	11c-acetate and 18F-FDG, and Cardiac MRI n=21 Participants 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.
Age, Continuous	54.4 years STANDARD_DEVIATION 15.9 • n=21 Participants
Sex: Female, Male Female	13 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=21 Participants
Region of Enrollment United States	21 participants n=21 Participants

Timeframe: 6 months

Population: Patient completed the cardiac MRI at 6 months, changes in RVEF

RV function as measured by cardiac MRI

Outcome measures
Measure	11c-acetate and 18F-FDG, and Cardiac MRI n=21 Participants 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.
Changes in RV Function	7.56 percentage Standard Error 1.72

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Pennsylvania

Phone: 215-662-2855