{"entity":{"id":"aurora-flurpiridaz","kind":"trial","name":"AURORA","aka":["International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI"],"tldr":"A new PET heart-imaging tracer called flurpiridaz was tested against the standard SPECT heart scan in people with suspected coronary artery disease, and found blocked arteries more reliably, especially in women and people with obesity, while using about half the radiation dose.","summary":"AURORA was the second (confirmatory) phase 3, prospective, multicentre trial of 18F-flurpiridaz, a novel PET myocardial perfusion imaging tracer, following an earlier phase 3 study that met its sensitivity endpoint but not its specificity non-inferiority criterion. AURORA enrolled 730 patients with suspected coronary artery disease across 48 sites in the US, Canada, and Europe; 578 were evaluable. Each patient underwent same-day rest/stress flurpiridaz PET and rest-stress 99mTc-labelled SPECT, both read blinded by three experts, before invasive coronary angiography (ICA) as the reference standard for ≥50% stenosis.\n\nFlurpiridaz PET met both co-primary efficacy endpoints: sensitivity was higher than SPECT (80.3% vs 68.7%, p=0.0003) and specificity was non-inferior (63.8% vs 61.7%, p=0.0004). The area under the receiver-operating-characteristic curve favoured PET overall (0.80 vs 0.68) and specifically in women and obese patients, two groups in whom SPECT image quality is often degraded by attenuation artefact. PET also reduced radiation exposure by roughly half compared with SPECT and improved image quality and diagnostic certainty. A prespecified obesity subgroup analysis published in 2026 confirmed the advantage held across BMI categories.\n\nAURORA supported FDA approval of flurpiridaz F-18 for PET myocardial perfusion imaging, giving cardiac PET a second widely available perfusion tracer alongside rubidium-82 and expanding access to PET myocardial perfusion imaging at centres with an on-site or nearby cyclotron rather than a generator.","status":"completed","asOf":"2026-09-22","links":[{"label":"JACC 2023: AURORA primary results (Maddahi et al.)","url":"https://pubmed.ncbi.nlm.nih.gov/37821170/"},{"label":"ClinicalTrials.gov: NCT03354273","url":"https://clinicaltrials.gov/study/NCT03354273"}],"tags":["diagnostic trial","cardiology","PET tracer","myocardial perfusion"],"related":["pet","pet-tracer-manufacturing","f-18","tc-99m","rb-82"],"indications":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03354273","phase":"3","setting":"Adults with suspected coronary artery disease undergoing myocardial perfusion imaging before invasive coronary angiography; a diagnostic (cardiac imaging) trial","sponsor":"GE HealthCare","result":"18F-flurpiridaz PET was more sensitive than 99mTc-SPECT for detecting ≥50% coronary stenosis (80.3% vs 68.7%, p=0.0003) with non-inferior specificity (63.8% vs 61.7%, p=0.0004), meeting both primary efficacy endpoints (Maddahi et al., JACC 2023)","yearReported":2023,"enrolled":730,"enrolledBasis":"registry","outcomes":[{"endpoint":"Sensitivity for coronary artery disease (≥50% stenosis by quantitative coronary angiography)","primary":true,"unit":"%","arms":[{"name":"18F-flurpiridaz PET","n":578,"value":80.3},{"name":"99mTc-SPECT","n":578,"value":68.7}],"p":"0.0003","source":"https://pubmed.ncbi.nlm.nih.gov/37821170/"},{"endpoint":"Specificity for coronary artery disease","primary":true,"unit":"%","arms":[{"name":"18F-flurpiridaz PET","n":578,"value":63.8},{"name":"99mTc-SPECT","n":578,"value":61.7}],"p":"0.0004","source":"https://pubmed.ncbi.nlm.nih.gov/37821170/"},{"endpoint":"Area under the ROC curve, overall population","unit":"AUC","arms":[{"name":"18F-flurpiridaz PET","value":0.8},{"name":"99mTc-SPECT","value":0.68}],"p":"<0.001"}]},"route":"/trials/aurora-flurpiridaz/","neighbours":{"technology":[{"id":"pet","kind":"technology","name":"PET (positron emission tomography)","route":"/technologies/pet/"},{"id":"pet-tracer-manufacturing","kind":"technology","name":"PET tracer manufacturing and distribution","route":"/technologies/pet-tracer-manufacturing/"}],"isotope":[{"id":"f-18","kind":"isotope","name":"Fluorine-18","route":"/isotopes/f-18/"},{"id":"rb-82","kind":"isotope","name":"Rubidium-82","route":"/isotopes/rb-82/"},{"id":"tc-99m","kind":"isotope","name":"Technetium-99m","route":"/isotopes/tc-99m/"}]}}