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Evaluation of XTR004 as a Novel 18F-labeled PET MPI Tracer in Diagnosis of Known or Suspected CAD

NCT05885841 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2023-06-02

No results posted yet for this study

Summary

The diagnostic efficacy and safety of the XTR004 myocardial perfusion PET imaging tracer are evaluated for known or suspected CAD with the use of invasive coronary angiography as the reference standard for the diagnosis of CAD and invasive pressure-temperature FFR/IMR as a reference for the detection of abnormal coronary function.

Conditions

  • Coronary Artery Disease (CAD)

Interventions

DRUG

XTR004

At rest: IV bolus injection of XTR004 with a dose range of 2.0-2.5 mCi At stress: IV infusion of adenosine at a rate of 140 μg/kg/min. IV bolus injection of XTR004 with a dose range of 6.0-7.5 mCi.

Sponsors & Collaborators

  • Sinotau Pharmaceutical Group

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2023-05-09
Completion
2023-05-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05885841 on ClinicalTrials.gov