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

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04596527
• Other study ID #: ZS-2514
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 15, 2020
• Est. completion date: September 2022

Study information

• Verified date: October 2020
• Source: Peking Union Medical College Hospital
• Contact: Peipei Wang, MD
• Phone: 18511395988
• Email: wpp199411[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
China	Peking union medical college hospital	Beijing	Dongcheng

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	good quality rate of images	18F-FMPP and 13N-ammonia PET MPI images	through study completion, an average of 2 years