Trial Outcomes & Findings for Fatty Acid Radiotracer Comparison Study in Heart Failure Patients (NCT NCT01648296)

Results Overview

The values in the table represent the number of participants, specifically Dosimetry and Kinetic patients and that is how the primary endpoint is arrived at. This is how the primary endpoint is determined through PET/CT measurements of Myocardial FA metabolism with F-18 Florbeta Ox. The data intended for this Outcome Measure use PET/CT images to visualize the amount of myocardial FA metabolism appears with the radio tracer, Florbeta Ox.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

50 participants

Primary outcome timeframe

24-72 hrs

Results posted on

2020-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	Dosimetry Group A total of 12 subjects will receive a single intravenous injection of\[18F\]FluorbetaOx followed by PET-CT imaging. Four normal healthy volunteer subjects and 8 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy. \[18F\]FluorbetaOx: Fluorine 18-labeled FluorbetaOx	Kinetic Dynamic Group A total of 38 subjects will receive a single intravenous injection of \[18F\]FluorbetaOx, \[11C\]Palmitate, and \[15O\]Water followed by PET-CT imaging. Ten normal healthy volunteer subjects and 28 subjects with or without Type 2 Diabetes Mellitus of which 18 subjects will have Chronic Dilated Cardiomyopathy and 10 obese subjects with a Body Mass Index of ≥ 30kg/m2. \[18F\]FluorbetaOx: Fluorine 18-labeled FluorbetaOx
Overall Study STARTED	11	17
Overall Study COMPLETED	11	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dosimetry Group n=11 Participants A total of 12 subjects will receive a single intravenous injection of\[18F\]FluorbetaOx followed by PET-CT imaging. Four normal healthy volunteer subjects and 8 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy. \[18F\]FluorbetaOx: Fluorine 18-labeled FluorbetaOx	Kinetic Dynamic Group n=17 Participants A total of 38 subjects will receive a single intravenous injection of \[18F\]FluorbetaOx, \[11C\]Palmitate, and \[15O\]Water followed by PET-CT imaging. Ten normal healthy volunteer subjects and 28 subjects with or without Type 2 Diabetes Mellitus of which 18 subjects will have Chronic Dilated Cardiomyopathy and 10 obese subjects with a Body Mass Index of ≥ 30kg/m2. \[18F\]FluorbetaOx: Fluorine 18-labeled FluorbetaOx	Total n=28 Participants Total of all reporting groups
Age, Continuous	46.5 years n=11 Participants	46.5 years n=17 Participants	46.5 years n=28 Participants
Sex: Female, Male Female	6 Participants n=11 Participants	8 Participants n=17 Participants	14 Participants n=28 Participants
Sex: Female, Male Male	5 Participants n=11 Participants	9 Participants n=17 Participants	14 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 24-72 hrs

Population: The PI has left the institution, all efforts to locate this data have been exhausted and it therefore cannot be reported

The values in the table represent the number of participants, specifically Dosimetry and Kinetic patients and that is how the primary endpoint is arrived at. This is how the primary endpoint is determined through PET/CT measurements of Myocardial FA metabolism with F-18 Florbeta Ox. The data intended for this Outcome Measure use PET/CT images to visualize the amount of myocardial FA metabolism appears with the radio tracer, Florbeta Ox.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2-3 days post [18F]FluorbetaOx injection

Population: The PI has left the institution, and all efforts to locate this data have been exhausted and it therefore cannot be reported.

A total of 0 subjects (Four normal healthy volunteer subjects and0 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy)will receive a single intravenous injection of 10 mCi of\[18F\]FluorbetaOx followed by PET-CT imaging at two separate time points. The difference between primary Outcome and the secondary outcome are the patients themselves. Florbeta Ox was measured in normal healthy volunteers and in non-ischemic cardiomyopathy patients through PET/CT image visualization.

Outcome measures

Outcome data not reported

Adverse Events

Dosimetry Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Kinetic Dynamic Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory

Washington University School of Medicine

Phone: 314-747-3877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place