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A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.

NCT01347710 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 795

Last updated 2020-11-24

Study results available
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Summary

The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI).

Conditions

Interventions

DRUG

Flurpiridaz F18

Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis

DRUG

99mTechnicium (sestamibi or tetrofosmin)

Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis

Sponsors & Collaborators

  • Lantheus Medical Imaging

    lead INDUSTRY

Principal Investigators

  • Cesare Orlandi, MD · Lantheus Medical Imaging

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-07-31
Completion
2013-09-30

Countries

  • United States
  • Canada
  • Finland
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01347710 on ClinicalTrials.gov