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

Primary Purpose

Coronary Disease

Status

Unknown status

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

18F-FMPP

About this trial

This is an interventional diagnostic trial for Coronary Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Peking union medical college hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Number of Participants with Adverse events

Number of participants and type of adverse events as a measure of safety

good quality rate of images

18F-FMPP and 13N-ammonia PET MPI images

Full Information

NCT ID

NCT04596527

First Posted

October 15, 2020

Last Updated

October 21, 2020

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04596527

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 15, 2020 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

18F-FMPP

Other Intervention Name(s)

XTR004

Intervention Description

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.

Primary Outcome Measure Information:

Title

The evaluation of diagnostic performance of 18F-FMPP PET MPI in the detection of CAD

Description

Defined by invasive coronary angiography in patients with suspected or known CAD

Time Frame

through study completion, an average of 2 years

Secondary Outcome Measure Information:

Title

Diagnostic rate of 18F-FMPP MPI in CAD patients

Description

Time Frame

through study completion, an average of 2 years

Title

Number of Participants with Adverse events

Description

Number of participants and type of adverse events as a measure of safety

Time Frame

through study completion, an average of 2 years

Title

good quality rate of images

Description

18F-FMPP and 13N-ammonia PET MPI images

Time Frame

through study completion, an average of 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peipei Wang, MD

Phone

18511395988

wpp199411@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Huo, PhD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking union medical college hospital

City

Beijing

State/Province

Dongcheng

ZIP/Postal Code

100010

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peipei Wang, MD

Phone

18511395988

wpp199411@163.com

First Name & Middle Initial & Last Name & Degree

Li Huo, PhD

Phone

13910801986

Huoli@pumch.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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