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

NCT04596527 | Unknown Early Phase 1

• 1 other identifier: ZS-2514
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Diagnostic rate of 18F-FMPP MPI in CAD patients

  through study completion, an average of 2 years

• Number of Participants with Adverse events

  through study completion, an average of 2 years

• good quality rate of images

  through study completion, an average of 2 years

Study Arms (1)

18F-FMPP PET MPI (following off-study 13N-ammonia PET MPI)

EXPERIMENTAL

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

Interventions

18F-FMPP DRUG

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.

Also known as: XTR004

18F-FMPP PET MPI (following off-study 13N-ammonia PET MPI)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking union medical college hospital

Beijing, Dongcheng, 100010, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Li Huo, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peipei Wang, MD

CONTACT

18511395988; wpp199411@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: September 15, 2020
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)