18F-FMPP PET MPI in the Detection of Coronary Artery Disease

Diagnostic Performance of 18F-FMPP PET Myocardial Perfusion Imaging in the Detection of Coronary Artery Disease: A Comparative Study With 13N-Ammonia PET

18F-FMPP is a novel PET myocardial perfusion imaging (MPI) tracer which targets to mitochondria complex I (MC-I). Preclinical animal studies have shown that its uptake is highly uniform and long in the heart and rather low in the liver. It may be a promising tracer for myocardial perfusion imaging. In addition, as a myocardial PET tracer, it is capable of quantifying absolute myocardial blood flow. Thus this prospective and open-label study is going to evaluate the diagnosis performance of 18F-FMPP PET MPI in suspected or known CAD patients who will be referred for invasive coronary angiography (ICA).

Study Overview

• Status: Unknown
• Conditions: Coronary Disease
• Intervention / Treatment: Drug: 18F-FMPP

Detailed Description

PET myocardial perfusion imaging (MPI) can provide not only qualitative images, but also absolute quantitation of myocardial blood flow (MBF) in the unit of ml/min/g to facilitate the early diagnosis of coronary disease (CAD). It can be more beneficial for patients with three-vessel disease, microvascular disease or obesity. At present, the diagnostic capability of 13N-ammonia PET MPI has been well studied, but its clinical usability is largely limited by short half-life. 18F-labeled MPI tracer (18F-FMPP) is a new type of PET tracer for MPI. Preclinical studies showed that 18F-FMPP has important characteristics such as high myocardial retention and low background uptake of adjacent organs, which may be a more ideal drug for PET MPI toward routine clinical utilization. Our study will assess the safety profile, image quality and diagnostic performance of 18F-FMPP PET in detection of CAD by using invasive coronary angiography as the reference standard. In addition, the investigators will further compare the diagnostic performance of 18F-FMPP PET MPI with that of 13N-ammonia PET MPI.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Dongcheng
    • Beijing, Dongcheng, China, 100010
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Peipei Wang, MD; Phone Number: 18511395988; Email: wpp199411@163.com
      • Contact: Li Huo, PhD; Phone Number: 13910801986; Email: Huoli@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed.
• At the time of enrolment, the subject has been scheduled via written documentation to undergo an ICA for the assessment of CAD.
• The subject at least has one or multiple risk factors for coronary heart disease, including hypertension, hyperlipidemia, hyperglycemia, smoking, family history, obesity, post-menopause.
• The subject presents typical symptoms for CAD such as dyspnea, chest tightness and chest pain.
• The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal.
• The subject is able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria:

• Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating.
• Patients incapable of undergoing pharmacological cardiac stress testing.
• Patients who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the patient during cardiac stress testing.
• Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF <50%).
• Patients whose images quality can not meet the requirements.
• Patients who are not suitable to participate in the trial according to researchers.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 18F-FMPP PET MPI (following off-study 13N-ammonia PET MPI); Imaging Procedure: 18F-FMPP PET Day 1: All subjects will receive rest and stress IV boluses of 18F-FMPP injections in a large peripheral vein. The dosages of 18F-FMPP Injection administered at rest and during stress conditions are 2.5 mCi and 6.0 mCi for an individual subject. Rest or stress PET imaging will be acquired for 20 minutes. The pharmacological stress will utilize ATP as the stressor. Imaging Procedure: 13N-Ammonia PET All subjects will receive 2 IV boluses of 13N-ammonia Injection in a large peripheral vein: 1 at rest and 1 during stress. The dosages of 13N-ammonia Injection administered at rest and during stress conditions is 20mCi and 20 mCi for an individual subject. Rest or stress PET imaging will be acquired for 20 minutes. The pharmacological stress will utilize ATP as the stressor.

Drug: 18F-FMPP; 18F-FMPP were injected into the patients at rest (2.5 mCi) and during stress (6.0 mCi) for an individual subject before PET/CT scans.; Other Names: XTR004

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The evaluation of diagnostic performance of 18F-FMPP PET MPI in the detection of CAD	Defined by invasive coronary angiography in patients with suspected or known CAD	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic rate of 18F-FMPP MPI in CAD patients	Diagnostic efficacy of 18F-FMPP PET MPI compared with 13N-ammonia PET MPI in the detection of CAD in patients with suspected or known CAD. Qualitative PET MPI alone. Absolute MBF quantitation alone. Added value of MBF quantitation	through study completion, an average of 2 years
Number of Participants with Adverse events	Number of participants and type of adverse events as a measure of safety	through study completion, an average of 2 years
good quality rate of images	18F-FMPP and 13N-ammonia PET MPI images	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Li Huo, PhD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: ZS-2514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No