A Head-to-Head Comparison of A New Perfusion Tracer, 99mTc-4BOH vs. 13N-NH3 to Evaluate Diagnostic Efficacy of Ischemic Heart Disease

May 19, 2025 updated by: China National Center for Cardiovascular Diseases

A Prospective, Single-Center, Head-to-Head Clinical Trial Comparing 99mTc-4BOH SPECT Myocardial Perfusion Imaging With 13N-Ammonia PET Imaging for the Diagnosis of Myocardial Ischemia, Using Invasive Coronary Angiography and Fractional Flow Reserve as the Reference Standard

The objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of 99mTc-4BOH SPECT myocardial perfusion imaging (MPI) compared to 13N-ammonia PET MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this trial is to evaluate whether SPECT myocardial perfusion using the novel tracer 99mTc-4BOH is non-inferior to 13N-ammonia PET in diagnosing myocardial ischemia in patients with fractional flow reserve (FFR) as the diagnostic gold standard. In this study, 13N-ammonia PET imaging will be used as the positive control. Patients with diagnosed CAD who are scheduled for myocardial perfusion imaging will be assigned to undergo head-to-head SPECT imaging with 99mTc-4BOH and PET imaging with 13N-ammonia, with no more than 7 days between scans. All participants will subsequently undergo coronary angiography with FFR measurement within 30 days of imaging. The diagnostic performance of 99mTc-4BOH will be compared to that of 13N-ammonia, using FFR as the reference standard.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 80 years. Presence of angina symptoms, such as chest tightness or chest pain. Coronary CT angiography (CTA) indicating ≥50% stenosis in at least one coronary artery.

Able and willing to provide written informed consent.

Exclusion Criteria:

  • Underwent coronary revascularization (PCI or CABG) within the past 6 months. Presence of non-ischemic heart disease or left ventricular ejection fraction (LVEF) <35%.

Contraindications to adenosine stress (e.g., bronchial asthma, second-degree or higher atrioventricular block, severe hypotension).

Pregnancy or lactation. Unable or unwilling to sign the informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cross-over Imaging with 99mTc-4BOH and 13N-ammonia
Participants will undergo both 99mTc-4BOH SPECT and 13N-ammonia PET myocardial perfusion imaging in a randomized sequence, with the two imaging procedures performed within 7 days of each other. Coronary angiography and FFR measurement will be conducted within 30 days following both imaging sessions.
Diagnostic test: 99mTc-4BOH SPECT myocardial perfusion imaging
Participants undergo myocardial perfusion imaging using the investigational radiotracer 99mTc-4BOH with SPECT. Imaging is performed according to a standardized protocol. Each participant receives both this SPECT imaging and a PET imaging procedure using 13N-ammonia, in a randomized sequence, within a 7-day interval.
Diagnostic test: 13N-ammonia PET myocardial perfusion imaging
Participants undergo myocardial perfusion imaging using 13N-ammonia with PET as the active comparator. This procedure is performed according to standard clinical protocols. Each participant also receives 99mTc-4BOH SPECT imaging in a randomized sequence, with both tests completed within a 7-day window.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of 99mTc-4BOH SPECT imaging for detecting myocardial ischemia, using FFR as the reference standard
Time Frame: Within 30 days after both imaging procedures
Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of 99mTc-4BOH SPECT myocardial perfusion imaging in detecting myocardial ischemia, compared to fractional flow reserve (FFR ≤0.80) as the diagnostic gold standard.
Within 30 days after both imaging procedures

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Non-inferiority of 99mTc-4BOH SPECT vs. 13N-ammonia PET in detecting myocardial ischemia
Time Frame: Within 30 days after imaging and FFR
Assessment of the non-inferiority of 99mTc-4BOH SPECT imaging compared to 13N-ammonia PET imaging in detecting myocardial ischemia, using FFR as the gold standard. Analysis will be based on paired comparison and pre-specified non-inferiority
Within 30 days after imaging and FFR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-GSP-TJ-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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