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

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ClinicalTrials.gov Identifier: NCT04596527
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Coronary Disease Drug: 18F-FMPP Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ammonia

Arms and Interventions
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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 Name: XTR004


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


Secondary Outcome Measures :
  1. Diagnostic rate of 18F-FMPP MPI in CAD patients [ Time Frame: through study completion, an average of 2 years ]

    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


  2. Number of Participants with Adverse events [ Time Frame: through study completion, an average of 2 years ]
    Number of participants and type of adverse events as a measure of safety

  3. good quality rate of images [ Time Frame: through study completion, an average of 2 years ]
    18F-FMPP and 13N-ammonia PET MPI images


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596527


Contacts
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Contact: Peipei Wang, MD 18511395988 wpp199411@163.com

Locations
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China, Dongcheng
Peking union medical college hospital Recruiting
Beijing, Dongcheng, China, 100010
Contact: Peipei Wang, MD    18511395988    wpp199411@163.com   
Contact: Li Huo, PhD    13910801986    Huoli@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Li Huo, PhD Peking Union Medical College Hospital
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04596527    
Other Study ID Numbers: ZS-2514
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases