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

NCT05885841 | Completed Phase 2

• 1 other identifier: STB-XTR004-201
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

coronary artery disease(CAD); positron emission tomography (PET)

Outcome Measures

Primary Outcomes (2)

• Qualitative reading and semi-qualitative MPI analysis (SSS and SDS)

  Sensitivity and specificity of XTR004 PET MPI for the detection of ≥50% and ≥70% threshold coronary stenosis. Sensitivity and specificity of XTR004 PET MPI for the detection of abnormal function of epicardial coronary (FFR\<0.8, IMR\<25), abnormal coronary microcirculation (FFR≥0.8, IMR≥25), abnormal of both (FFR\<0.8, IMR≥25), and their corresponding thresholds.

  Day 1

• Quantitative index of XTR004 PET myocardial blood flow (Stress MBF, MFR)

  Sensitivity and specificity of XTR004 PET myocardial blood flow quantitative index (stress MBF, MFR) for the detection of ≥50% and ≥70% threshold coronary stenosis. Sensitivity and specificity of XTR004 PET MPI for the detection of abnormal function of epicardial coronary (FFR\<0.8, IMR\<25), abnormal coronary microcirculation (FFR≥0.8, IMR≥25), abnormal of both (FFR\<0.8, IMR≥25), and their corresponding thresholds.

  Day 1

Secondary Outcomes (1)

• Number of study participants with treatment-related adverse events as determined by safety parameter changes according to CTCAE v5.0

  7 days post-injection

Study Arms (1)

XTR004

EXPERIMENTAL

In the resting stage, subjects will receive an IV bolus injection of XTR004 to assess myocardial perfusion and myocardial blood flow. Under the pharmacological stress stage with adenosine, subjects will receive another IV bolus injection of XTR004 to assess myocardial perfusion and myocardial blood flow.

Drug: XTR004

Interventions

XTR004 DRUG

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.

XTR004

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female aged between 18 and 75 years old.
• Symptoms associated with known or suspected CAD.
• Having at least one risk factor for CAD, including hypertension, hyperlipidemia, diabetes, obesity, alcoholism, smoking, family history of CAD, postmenopausal women, or old age.
• Subjects who need invasive coronary angiography and function tests based on their routine clinical examination.
• Subjects who can understand, sign, and date the written informed consent.

You may not qualify if:

• Severe cardiovascular disease, including but not limited to an acute coronary syndrome, second or third-degree atrioventricular, sinoatrial block, NYHA class iii and iv, heart failure, dilated or hypertrophic cardiomyopathy, etc., and have been assessed by the investigator as unsuitable to participate in this study.
• Severe acute or chronic lung disease, including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, emphysema, pulmonary fibrosis, pulmonary embolism, pneumonia, etc., and have been assessed by the investigator as unsuitable to participate in this study.
• Severe or unstable central nervous system disease, including but not limited to unstable cerebrovascular disease, active epilepsy, infectious disease of the central nervous system, etc., and have been assessed by the investigator as unsuitable to participate in this study.
• Severe bleeding disorders or coagulation disorders, including but not limited to purpura, hemophilia, vitamin K deficiency, etc., and have been assessed by the investigator as unsuitable to participate in this study.
• Severe liver disease, including but not limited to viral hepatitis, autoimmune hepatitis, liver cirrhosis, liver cancer, etc., and have been assessed by the investigator as unsuitable to participate in this study.
• Severe renal impairment, including but not limited to glomerular nephropathy, hydronephrosis, renal cysts, etc., and have been assessed by the investigator as unsuitable to participate in this study.
• Patients with febrile or active infectious disease, and have been assessed by the investigator as unsuitable to participate in this study.
• Patients with serious disease of other organ systems other than those not mentioned above and have been assessed by the investigator as unsuitable to participate in this study.
• Known to be allergic to adenosine.
• Severe allergic reaction to alcohol.
• Known to be allergic to iodine contrast tracers.
• Significant occupational exposure to or treatment with ionizing radiation (e.g., more than 50 mSv/yr) within 10 years.
• Pregnancy or lactating woman.
• Patients with mental disorders or poor compliance.
• Those who have participated in another clinical study 30 days before enrollment or during follow-up.

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Study Sites (2)

Beijing Hospital

Beijing, Beijing Municipality, 100051, China

Location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100176, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2022
• First Posted: June 2, 2023
• Study Start: February 15, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

CN (2)