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

2014-08-27 03:41:01 | BioPortfolio

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.

Description

CardioPET™ is a modified fatty acid (MFA) that closely resembles naturally-occurring free fatty acids (FFAs) in the human body.

Study Procedures:

Visit 1: Screening - Eligibility determination

Visit 2: Injection and PET Imaging

Visit 3: Follow-up Visit

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Coronary Artery Disease

Intervention

CardioPET

Location

Massachusetts General Hospital
Boston
Massachusetts
United States
02114

Status

Completed

Source

Fluoropharma, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:41:01-0400

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