Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI

Lantheus Medical Imaging

Status and phase: Withdrawn; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: Flurpiridaz F18

Study type: Interventional

Funder types: Industry

Identifiers

NCT01681524

BMS747158-302

Details and patient eligibility

About

The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to determine if the study drug in PET imaging is better than SPECT imaging currently used for this purpose.

Full description

The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI in comparison with SPECT MPI in patients with known or suspected CAD. Six hundred and seventy-two evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention (being either positive or negative for CAD).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Invasive Coronary Angiography Men or Women age 18 or older - see protocol for additional details

Exclusion criteria

Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control Unstable cardiac status History of coronary artery bypass graft History of PCI within the past six months See protocol for additional details

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Flurpiridaz F18

Experimental group

Description:

Open-label study of a single injection of flurpiridaz F18 for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary cathertization

Treatment:

Drug: Flurpiridaz F18