Flurpiridaz F 18 safe, effective in early diagnostic trials

Berman DS. J Am Coll Cardiol. 2013;61:469-477.

  • January 28, 2013

PET myocardial perfusion imaging with flurpiridaz F 18 yielded quality images, interpretive certainty and good overall CAD diagnosis, according to phase 2 trial data.

Flurpiridaz F 18, labeled with positron-emitting isotope F-18, was developed as a myocardial perfusion imaging (MPI) radiopharmaceutical for PET. Researchers assessed the clinical safety of flurpiridaz F 18 in a phase 2 trial. The study included 143 patients (mean age, 62 years; 107 men) from 21 centers who underwent rest-stress PET and Tc-99m single-photon emission computed tomography MPI. Eighty-six patients underwent invasive coronary angiography, 39 of whom had low-likelihood of CAD, according to the study abstract.

Daniel S. Berman, MD 

Daniel S. Berman

More images were rated as excellent or good on PET with flurpiridaz F 18, as compared with SPECT, on both stress images (99.2% vs. 88.5%; P<.01) and rest images (96.9% vs. 66.4%, P<.01).

PET was associated with a greater percentage of cases with definitely abnormal/normal interpretation when compared with SPECT (90.8% vs. 70.9%; P<.01).

In the 86 patients who underwent invasive coronary angiography, PET had a higher sensitivity (78.8% vs. 61.5%; P<.01), but no different specificity (76.5% vs. 73.5%) than SPECT. In other results, the receiver-operating characteristic curve area was 0.82 for PET and 0.8 for SPECT (P=.04) and normalcy rate was 89.7% for PET and 97.4% for SPECT.

PET was also linked with greater magnitude of reversible defects in patients with CAD on invasive coronary angiography (P=.008).

In this cohort, flurpiridaz F 18 was found safe, according to extensive safety assessment.

In addition, the researchers noted that radiation doses of the flurpiridaz F 18 tracer are two times lower than doses in standard rest or stress Tc-99m SPECT MPI protocols.

“These findings suggest that this new tracer might significantly improve the assessment of patients with radionuclide MPI compared with the standard SPECT MPI methods,” Daniel S. Berman, MD, a Cardiology Today Editorial Board member, and colleagues concluded.

Disclosure: See the full study for a list of the researchers’ relevant financial disclosures.

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