A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET

NCT00733460 | Completed Phase 1

• 1 other identifier: BFPET P-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and dosimetry of BFPET™ will be evaluated in healthy volunteers and Coronary Artery Disease (CAD) patients , male or female and of age ranging between 20-80 years old.

Conditions

Coronary Artery Disease

Keywords

BFPET; Coronary Artery Disease; Myocardial Perfusion Imaging; Radiation Dosimetry

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure. Safety Biodistribution Radiation dosimetry

  Change in vital signs, physical examination, ECG measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose. Change in 12-lead Electrocardiogram measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose. Change in 24-hour Holter (initiated 2 hours pre-dose, continuous for 24 hours, time stop recorded. Change in dosimetry sampling (blood and urine)blood measured at time 0 (immediately following injection), 1,5, 15, 30, 60, 90 minutes. Adverse event assessment immediate post dose, 24-48 hours and 7 days post-dose.

  pre-dose, post-dose 0, 1, 5, 15, 30, 60 and 90 minutes, 2 hours, 24-48 hours post-dose and 7 days post-dose.

Secondary Outcomes (1)

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

  30, 60, 120, and 240 seconds.

Study Arms (1)

BF-PET

EXPERIMENTAL

Drug: BFPET

Interventions

BFPET DRUG

BF-PET

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must provide written informed consent prior to any study related procedures;
• Subject must be ≥ 20 and ≤ 80 years of age;
• Subject must have a serum creatinine within the investigational site's normal range.
• Subject must have liver function tests \< 1.5 times the investigational site's normal range.
• Subject must have a hematocrit level within 5% of the investigational site's normal range.

You may not qualify if:

• 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;
• Any exposure to any investigational drugs within four (4) weeks prior to Visit 1;
• Any exposure to investigational 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 Pregnancy Test, or the possibility of pregnancy cannot be ruled out prior to dosing or is breast-feeding. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH.
• Subject has experienced any allergic reaction to similar radiofluorinated compounds or agents.
• CORONARY ARTERY DISEASE (CAD) SUBJECTS
• Subjects must provide written informed consent prior to any study related procedures;
• Subjects must be ≥ 20 and ≤ 80 years of age;
• 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 6 months;
• Percutaneous coronary intervention (PCI), with stent placement within six months;
• Blood pressure over 180/100;

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

• Henry Gewirtz, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 13, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 10, 2013

Record last verified: 2013-06

Locations

US (1)