Coronary Artery Disease (CAD)Phase 2NCT05885841
Evaluation of XTR004 as a Novel 18F-labeled PET MPI Tracer in Diagnosis of Known or Suspected CAD
A Phase 2 study testing XTR004 in people with Coronary Artery Disease (CAD), run by Sinotau Pharmaceutical Group at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- XTR004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesChina
- Study dates
- 15 Feb 2022to 9 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Men and women of reproductive age refused to adopt contraceptive plans during the study period and 6 months after the study ended.
- Other circumstances that the investigator considers inappropriate for participating in the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Hospital
Beijing, Beijing Municipality, 100051
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100176
About this study
Official title: Evaluation of XTR004 as a Novel 18F-labeled PET Myocardial Perfusion Imaging (MPI) Tracer in Diagnosis of Known or Suspected CAD Compared With Invasive Coronary Angiography, Fractional Flow Reserve, Index of Microcirculatory Resistance
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.
Read the detailed description
A phase II study that is single-arm, open-label, multi-center, and self-controlled with the following objectives;
- Quantitative diagnostic efficacy of XTR004 perfusion imaging tracer in the diagnosis of known or suspected CAD using invasive coronary angiography as a reference standard for CAD.
- The effectiveness of XTR004 myocardial perfusion imaging tracer in the detection of CAD using a pressure-temperature guide wire fractional flow reserve (FFR), and index of microcirculation resistance (IMR) as a reference standard to confirm abnormal coronary blood flow reserve and microvascular disfunction.
- Subjects' safety after two doses of XTR004 intravenous injection.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- XTR004
- Keywords
- coronary artery disease(CAD), positron emission tomography (PET)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XTR004Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: XTR004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Safety parameters included adverse events, vital signs (body temperature, blood pressure, respiration rate, pulse rate), physical examinations, laboratory tests (serum cardiac biomarkers, cardiac troponin I, serum biochemistry, haematology, and urinalysis) and electrocardiograms.
Measured: 7 days post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start15 Feb 2022
- Primary completion9 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinotau Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885841
- Sponsor's protocol ID
- STB-XTR004-201
- Status last verified
- May 2023
- First submitted
- 25 Dec 2022
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of XTR004 as a Novel 18F-labeled PET Myocardial Perfusion Imaging (MPI) Tracer in Diagnosis of Known or Suspected CAD Compared With Invasive Coronary Angiography, Fractional Flow Reserve, Index of Microcirculatory Resistance
- ClinicalTrials.gov ID
- NCT05885841
- Acronym / sponsor ID
- STB-XTR004-201
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- coronary artery disease(CAD), positron emission tomography (PET)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A phase II study that is single-arm, open-label, multi-center, and self-controlled with the following objectives;
- Quantitative diagnostic efficacy of XTR004 perfusion imaging tracer in the diagnosis of known or suspected CAD using invasive coronary angiography as a reference standard for CAD.
- The effectiveness of XTR004 myocardial perfusion imaging tracer in the detection of CAD using a pressure-temperature guide wire fractional flow reserve (FFR), and index of microcirculation resistance (IMR) as a reference standard to confirm abnormal coronary blood flow reserve and microvascular disfunction.
- Subjects' safety after two doses of XTR004 intravenous injection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XTR004 | Experimental | Drug: XTR004In 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XTR004At 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. | Drug | XTR004 |
Primary outcome
Qualitative reading and semi-qualitative MPI analysis (SSS and SDS)
Time frame: Day 1
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.
Quantitative index of XTR004 PET myocardial blood flow (Stress MBF, MFR)
Time frame: Day 1
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.
1 secondary outcome
Number of study participants with treatment-related adverse events as determined by safety parameter changes according to CTCAE v5.0
Time frame: 7 days post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XTR004 in people with Coronary Artery Disease (CAD), run by Sinotau Pharmaceutical Group at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative reading and semi-qualitative MPI analysis (SSS and SDS) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.