A Phase I Study in Healthy Volunteers to Evaluate the Safety of CardioPET™ in Detection of Coronary Artery Disease

NCT00413647 | Completed Phase 1

• 1 other identifier: CardioPET P-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD subjects both male and female between the ages of 50-85. Nine normal controls will undergo repeated whole body imaging for biodistribution and dosimetry estimation. Six other normal healthy subjects will undergo heart imaging only. Six CAD subjects will undergo heart imaging only.

Conditions

Coronary Artery Disease

Keywords

CardioPET; Coronary Artery Disease; Electrocardiogram; Radiation Dosimetry

Outcome Measures

Primary Outcomes (1)

• Change in vital signs. Change in physical examination. Change in ECG. Change in 24-hour Holter. Change in dosimetry (blood and urine)measured at time 0 (immediately folloing injection), 1, 5, 15, 30, 60, and 90 minutes. Adverse event assessment.

  Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging.

  Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events).

Secondary Outcomes (2)

• Performance characteristics of CardioPET as a PET tracer for myocardial imaging.

  0, 1 min, 5 min, 15 min, 30 min, 60 min, and 90 min.

• Evaluation and optimization of the methods of image acquisition, output processing, display, reconstruction, and imaging data

  Baseline, 15 second time frames for first 2 minutes, 1 min. time frame for next 8 min., 2 min frames for remainder of 60 min study.

Study Arms (1)

CardioPET

EXPERIMENTAL

Drug: CardioPET

Interventions

CardioPET DRUG

CardioPET

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal Healthy Volunteers:
• Subject must provide written informed consent prior to any study related procedures
• Subjects must be between the ages of 50 and 85 years of age.
• Coronary Artery Disease (CAD) subjects:
• Subjects must provide written informed consent prior to any study related procedures;
• Subjects must be ≥ 50 and ≤ 85 years of age;
• Subject must have history of CAD documented by an exercise stress Myocardial Perfusion Imaging (MPI) study within 6 months documenting myocardial infarct without ischemia.

You may not qualify if:

• Normal Healthy Volunteers:
• Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
• Any clinically significant abnormality in the screening laboratory tests or ECG
• Fasting blood glucose level over 120 mg/dl
• Any exposure to any investigational drugs with four(4)weeks prior to Visit 1
• Any exposure to radiopharmaceuticals within four(4)weeks prior to the date of Visit 1
• Any new prescription medications within four(4)weeks of Visit 1
• Subject has a Positive(+)Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH
• Coronary Artery Disease (CAD) Subjects:
• Subject has a Positive (+) Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing;
• Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
• Coronary artery bypass graft (CABG) within 1 year;
• Percutaneous coronary intervention (PCI), with stent placement within three months;
• Blood pressure over 180/100;
• Acute changes in ECG;

Sponsors & Collaborators

• Fluoropharma, Inc.: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Alan J. Fischman, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 20, 2006
• Study Start: September 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

US (1)