Fatty Acid Radiotracer Comparison Study in Heart Failure Patients

NCT01648296 | Completed Early Phase 1 Results DMC

• 2 other identifiers: IND113344IRB#201208087
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A single center, open-label baseline controlled imaging study to designed to assess whether Positron Emission Tomography (PET) measurements of myocardial Fatty Acid (FA) metabolism performed with \[18F\]FluorbetaOx correlates with measurements using \[11C\]palmitate. This study involves the investigational use of a PET radioactive tracer, fluorine-18 radiolabeled fatty acid analog, \[18F\]FluorbetaOx designed to measure beta oxidation of fatty acids in the myocardium. The investigators propose to evaluate the feasibility of the method in heart failure patients with dilated non-ischemic cardiomyopathy (DCM) with or without type-2 diabetes mellitus (T2DM) and obese subjects (Body Mass Index of ≥ 30kg/m2) with or without T2DM and normal healthy subjects to provide a wide range of perturbations in myocardial FA metabolism. Specific objectives include:

1. 1.To assess the diagnostic quality of \[18F\]FluorbetaOx PET images and kinetics at the proposed 10 millicurie (mCi) dose.
2. 2.To quantitatively determine the relationship between PET measurements of myocardial FA metabolism obtained with \[18F\]FluorbetaOx and those using \[11C\]Palmitate.
3. 3.To calculate human dosimetry based on the human biodistribution of \[18F\]FluorbetaOx.
4. 4.Correlate measurements of myocardial FA metabolism with changes in left ventricular (LV)structure and function performed on a clinically indicated echocardiography at 6-9 months after imaging.

Conditions

Heart Failure; Obesity; Type 2 Diabetes Mellitus; Health Normal Volunteer Subjects

Keywords

Heart Failure; Obesity; Type 2 Diabetes Mellitus; Health Normal Volunteer Subjects

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint is to Determine if PET/CT Measurements of Myocardial FA Metabolism Performed With [18F]FluorbetaOx Correlated With Those Performed With [11C]Palmitate and Calculation of Human Dosimetry.

  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.

  24-72 hrs

Secondary Outcomes (1)

• To Determine Human Dosimetry Based on the Human Biodistribution of [18F](+/-)NOS in Both Normal Healthy Volunteers and Dilated Non-ischemic Cardiomyopathy Patients.

  2-3 days post [18F]FluorbetaOx injection

Study Arms (2)

Dosimetry Group

EXPERIMENTAL

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.

Drug: [18F]FluorbetaOx

Kinetic Dynamic Group

EXPERIMENTAL

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.

Drug: [18F]FluorbetaOx

Interventions

[18F]FluorbetaOx DRUG

Fluorine 18-labeled FluorbetaOx

Also known as: IND #113344

Dosimetry Group; Kinetic Dynamic Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent
• Chronic dilated cardiomyopathy of non-ischemic origin
• New York Heart Association (NYHA)Class II/III heart failure for a minimum of 6 months prior to enrollment
• Heart Failure patients with Left Ventricular Ejection Fracture less than or equal to 35%
• Obesity defined as Body Mass Index of ≥ 30kg/m2
• Type 2 Diabetes Mellitus based on standard American Diabetes Association (ADA) criteria
• Capable of giving informed consent
• Not currently pregnant or nursing: Female subjects must be either: surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of \[18F\] FluorbetaOx is negative

You may not qualify if:

• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
• A recent positive pre-study drug/alcohol screen noted in medical records
• Pregnant females as determined by positive (serum or urine) human chorionic gonadotropin(hCG) test at screening or prior to dosing
• Lactating females
• Unwillingness or inability to follow the procedures outlined in the protocol
• Subject is mentally or legally incapacitated
• History of a psychiatric disorder that will affect the subject's ability to participate in the study
• Restrictive, obstructive, or infiltrative cardiomyopathy; pericardial disease; uncorrected thyroid disease (TSH) noted in medical records
• History of clinically significant coronary artery disease (CAD)including (prior (ST) elevation myocardial infarction, presence of ≥ 50% obstruction of a major coronary artery, and presence of angina)
• Contraindications to PET scanning (i.e., inability to lie flat with arms over head for up to 1½ hours; claustrophobia; current participation in research studies involving radiation exposure such that the total research-related radiation dose to the subject in any given year would exceed the Code of Federal Regulation limits

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Heart Failure; Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

There are no limitations and caveats

Results Point of Contact

• Title: Robert Gropler, MD, Chief of Cardiovascular Imaging Laboratory
• Organization: Washington University School of Medicine

groplerr@mir.wustl.edu

314-747-3877

Study Officials

• Robert J Gropler, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 24, 2012
• Study Start: September 13, 2012
• Primary Completion: June 4, 2014
• Study Completion: June 4, 2014
• Last Updated: February 24, 2020
• Results First Posted: November 27, 2019

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)