18F-flurpiridaz Imaging for Heart Disease

Overseen By Barbara Blanchfield

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Akiva Mintz

Must not be taking: PSMA-targeted therapy

Disqualifiers: Radiation exposure, Claustrophobia, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using PET imaging to examine heart disease. Researchers aim to significantly reduce the radiation from the scans while maintaining high-quality heart images. Individuals with known or suspected coronary artery disease, particularly those with chest pain or shortness of breath, may be suitable candidates. Participants will receive a small amount of a special tracer, 18F-flurpiridaz, followed by a PET scan lasting up to three hours. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on PSMA-targeted therapy while participating.

What prior data suggests that this imaging technique is safe for detecting coronary artery disease?

Research has shown that 18F-flurpiridaz, the tracer used in this imaging trial, is safe for humans. Studies have found it to be well-tolerated, with accurate measurement of radiation dose and distribution in the body. One study provided clearer heart images with this tracer compared to other methods, while maintaining safety. Another study confirmed its safety and effectiveness in the body. Overall, evidence suggests that 18F-flurpiridaz is a safe choice for heart imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-flurpiridaz imaging for heart disease because it offers a way to reduce radiation exposure significantly compared to standard PET scans. This technique uses an ultralow dose of the radiotracer, cutting radiation by 10-100 times, which is a big step forward for patient safety. Furthermore, it aims to improve image quality and optimize the timing of scans, potentially leading to more accurate diagnoses without the higher risks associated with traditional methods. This innovation could make heart disease detection safer and more precise.

What evidence suggests that this imaging technique is effective for detecting coronary artery disease?

Research shows that 18F-flurpiridaz holds promise for heart disease imaging. Studies have found it more effective at detecting heart issues than other imaging methods. Specifically, one study found an 80.3% success rate in identifying heart problems. It also produced fewer false alarms, demonstrating its accuracy. Early results suggest it is safe and provides clear images, making it a strong option for detecting coronary artery disease. Overall, 18F-flurpiridaz could offer improved and safer heart imaging. Participants in this trial will join an ultralow dose 18F-flurpiridaz imaging group to evaluate image quality and optimize timing and reconstruction after reducing radiation doses. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with known or suspected coronary artery disease, including those who have had a heart attack or are healthy but at risk of heart disease. Participants will undergo an advanced PET scan using a new technique intended to significantly reduce radiation exposure.

Inclusion Criteria

I am 18 years old or older.

Ability to provide informed consent and comply with study procedures

I am not pregnant or breastfeeding, and if capable of bearing children, I have a negative pregnancy test.

Exclusion Criteria

More than four prior enrollments in this study

Inability to provide informed consent

Any condition that, in the investigator's judgment, may compromise participant safety or study integrity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo ultralow dose PET imaging with 18F-flurpiridaz to evaluate image quality and optimize timing and reconstruction

Up to 3 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

12 months

Annual evaluation based on pooled images

What Are the Treatments Tested in This Trial?

Interventions

• 18F-flurpiridaz

Trial Overview

The study tests an ultralow dose PET imaging method using the radioactive tracer 18F-flurpiridaz on a high sensitivity scanner. The aim is to optimize timing and image quality while reducing radiation by up to 100 times compared to standard methods.

How Is the Trial Designed?

Group I: ultralow dose 18F-flurpiridaz imaging group Experimental Treatment 1 Intervention

Participants will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours

Who Is Running the Clinical Trial?

Akiva Mintz

Lead Sponsor

Trials

1

Recruited

40+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12577805/

Flurpiridaz F18: a new era in nuclear cardiac imaging

Clinical trials, namely the AURORA Phase III study, establish that Flurpiridaz PET imaging had higher sensitivity (80.3%) and non-inferior specificity (63.8%) ...

2.

acc.org

acc.org/Latest-in-Cardiology/Articles/2025/07/21/10/38/18F-Flurpiridaz-PET-MPI

18F Flurpiridaz PET MPI: New Horizons in Cardiac Imaging

The results of initial phase 1 studies demonstrated that 18F flurpiridaz is safe, with favorable dosimetry and biodistribution profiles.5. A ...

3.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCIMAGING.125.019142

Relative Flow Reserve and 18F-Flurpiridaz: Help, Hype, or ...

Flurpiridaz has extraordinarily high falsely positive relative stress flow (RFR) images for small, nonischemic, clinically insignificant, ...

4.

jacc.org

jacc.org/doi/10.1016/j.jacc.2023.08.016

Flurpiridaz F-18 PET Myocardial Perfusion Imaging in ...

A total of 578 patients (age 63.7 ± 9.5 years) were evaluable; 32.5% were women, 52.3% had body mass index ≥30 kg/m2, and 33.6% had diabetes.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1050173825000490

18F labeled myocardial perfusion PET: New precision in ...

In the first study in 795 patients, Flurpiridaz PET exhibited higher sensitivity (71.9 % vs. 53.7 %) and comparable specificity to SPECT, while delivering ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4316725/

Flurpiridaz F 18 PET: Phase II Safety and Clinical ...

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

7.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCIMAGING.125.018323

Utility of 18F-Flurpiridaz PET Relative Flow Reserve in ...

Utility of 18F-Flurpiridaz PET Relative Flow Reserve in Differentiating Obstructive From Nonobstructive Coronary Artery Disease.

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1071358123063754

Dosimetry, biodistribution, and safety of flurpiridaz F 18 in ...

F-labeled flurpiridaz was found to be safe and well tolerated. New Knowledge Gained. 18F-labeled flurpiridaz can be conveniently used for PET myocardial ...