Evidence map›Paper›PMID 23265345›Full record

Trial reportJournal of the American College of Cardiology2013

Phase II safety and clinical comparison with single-photon emission computed tomography myocardial perfusion imaging for detection of coronary artery disease: flurpiridaz F 18 positron emission tomography.

Daniel S Berman, Jamshid Maddahi, B K Tamarappoo, Johannes Czernin, Raymond Taillefer, James E Udelson, C Michael Gibson, Marybeth Devine, Joel Lazewatsky, Gajanan Bhat and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of the American College of Cardiology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07761728 (Comparative Evaluation of 18F-Flurpiridaz and 82Rb-Chloride PET Myocardial Perfusion Imaging), which is not on this map. Cited by 91 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07761728 enrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Comparative Evaluation of 18F-Flurpiridaz and 82Rb-Chloride PET Myocardial Perfusion Imaging: The FLARE (Flurpiridaz vs. Rubidium Evaluation) Trial

TypeobservationalSponsorUniversity of California, Los AngelesRan2025 to 2027Enrolled60ConditionsCoronary Artery Disease, Coronary Microvascular Disease
3 · Its place in the literature

Who cites it

91 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Improved assessment of coronary artery disease in obese patients with flurpiridaz-Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology · 2026
    Trial
  3. Utility ofCirculation. Cardiovascular imaging · 2025
    Trial
  4. Subendocardial quantification enhances coronary artery disease detection inEuropean journal of nuclear medicine and molecular imaging · 2025
    Trial
  5. Automatic motion correction for myocardial blood flow estimation improves diagnostic performance for coronary artery disease inJournal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology · 2025
    Trial
  6. Trial
  7. Trial
  8. Added value of myocardial blood flow usingJournal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology · 2021
    Trial
  9. Trial
  10. Trial
  11. American journal of nuclear medicine and molecular imaging · 2026
    Review
  12. Article
  13. Technical evaluation of immediate back-to-back rest-stress positron emission tomography scanning withJournal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology · 2025
    Article
  14. FDA Approval ofJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2025
    Article
  15. Comparative evaluation of a novel [European journal of nuclear medicine and molecular imaging · 2025
    Article
  16. Review
  17. Flurpiridaz F 18: First Approval.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2025
    Review
  18. Expanding the repertoire ofJournal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology · 2024
    Article
  19. Review
  20. Review

31 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Daniel S BermanDepartments of Imaging and Medicine, the Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: bermand@cshs.org.
Jamshid MaddahiDepartments of Molecular Medicine and Pharmacology, David Geffen School of Medicine at UCLA, Los Angeles, California.
B K TamarappooDepartments of Imaging and Medicine, the Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Johannes CzerninDepartments of Molecular Medicine and Pharmacology, David Geffen School of Medicine at UCLA, Los Angeles, California.
Raymond TailleferHôpital Hôtel-Dieu de Montréal, Montréal, Quebec, Canada.
James E UdelsonDivision of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts.
C Michael GibsonPerfuse Study Group, Boston, Massachusetts.
Marybeth DevineLantheus Medical Imaging, North Billerica, Massachusetts.
Joel LazewatskyLantheus Medical Imaging, North Billerica, Massachusetts.
Gajanan BhatLantheus Medical Imaging, North Billerica, Massachusetts.
Dana WashburnLantheus Medical Imaging, North Billerica, Massachusetts.

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024989 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$53.7M
Clinical and Translational Science Collaborative of ClevelandKL2TR000440 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$11.1M
NCATS NIH HHS KL2 TR000440NCRR NIH HHS UL1 RR024989
6 · The paper itself

Abstract

objectivesThis was a phase II trial to assess flurpiridaz F 18 for safety and compare its diagnostic performance for positron emission tomography (PET) myocardial perfusion imaging (MPI) with Tc-99m single-photon emission computed tomography (SPECT) MPI with regard to image quality, interpretative certainty, defect magnitude, and detection of coronary artery disease (CAD) (≥50% stenosis) on invasive coronary angiography (ICA).

backgroundIn pre-clinical and phase I studies, flurpiridaz F 18 has shown characteristics of an essentially ideal MPI tracer.

methodsOne hundred forty-three patients from 21 centers underwent rest-stress PET and Tc-99m SPECT MPI. Eighty-six patients underwent ICA, and 39 had low-likelihood of CAD. Images were scored by 3 independent, blinded readers.

resultsA higher percentage of images were rated as excellent/good on PET versus SPECT on stress (99.2% vs. 88.5%, p < 0.01) and rest (96.9% vs. 66.4, p < 0.01) images. Diagnostic certainty of interpretation (percentage of cases with definitely abnormal/normal interpretation) was higher for PET versus SPECT (90.8% vs. 70.9%, p < 0.01). In 86 patients who underwent ICA, sensitivity of PET was higher than SPECT (78.8% vs. 61.5%, respectively, p = 0.02). Specificity was not significantly different (PET: 76.5% vs. SPECT: 73.5%). Receiver-operating characteristic curve area was 0.82 ± 0.05 for PET and 0.70 ± 0.06 for SPECT (p = 0.04). Normalcy rate was 89.7% with PET and 97.4% with SPECT (p = NS). In patients with CAD on ICA, the magnitude of reversible defects was greater with PET than SPECT (p = 0.008). Extensive safety assessment revealed that flurpiridaz F 18 was safe in this cohort.

conclusionsIn this phase 2 trial, PET MPI with flurpiridaz F 18 was safe and superior to SPECT MPI for image quality, interpretative certainty, and overall CAD diagnosis.

Indexed as

Positron-Emission TomographyPyridazinesTechnetium Tc 99m SestamibiTomography, Emission-Computed, Single-PhotonCoronary AngiographyCoronary Artery DiseaseCoronary CirculationExercise TestFemaleHumansMaleMiddle AgedMyocardial Perfusion ImagingRadiopharmaceuticalsReproducibility of ResultsROC CurveBMS 747158-02PyridazinesRadiopharmaceuticalsTechnetium Tc 99m Sestamibi

Identifiers

PMID23265345
PMCPMC4316725

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.