Myocardial Perfusion ImagingPhase 2NCT07187895
Comparative Imaging of XTR004 PET and MIBI SPECT in Borderline Coronary Stenosis
A Phase 2 study testing XTR004 in people with Myocardial Perfusion Imaging and Diagnostic Certainty, run by Sinotau Pharmaceutical Group at 1 site in China.
Trial summary
Compare the diagnostic certainty of MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Perfusion Imaging, Diagnostic Certainty, Stable Coronary Artery Disease
- 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
- 17 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2024to 5 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Male or female participants aged 18 years or older.
- 2.Suspected or known stable coronary artery disease with related symptoms and stable condition, and having at least one coronary artery disease risk factor, including: hypertension, hyperlipidemia, diabetes, obesity, alcohol abuse, smoking, family history of coronary artery disease, postmenopausal status in women, or advanced age.
- 3.Underwent coronary CTA within the past 6 months showing 30%-90% stenosis, or indicating mild to moderate-to-severe stenosis.
- 4.Able to communicate effectively with the investigators, understand and comply with the clinical study requirements, voluntarily participate in the study, and provide written informed consent.
Who cannot join
- 1. Patients with a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
- 2.Patients with a prior diagnosis of myocardial infarction, congenital heart disease, cardiomyopathy, myocarditis, or other cardiac diseases.
- 3.Patients known to have severe allergic reactions to alcohol.
- 4.Patients known to have an allergy or other contraindications to adenosine.
- 5.Patients known to be allergic to iodinated contrast agents.
- 6.Individuals with significant occupational exposure to ionizing radiation within the past 10 years (e.g., exceeding 50 mSv/year), or exposure to radioactive substances or ionizing radiation for therapeutic or research purposes.
Show all 11Show fewer
- 7.Men and women of childbearing potential who do not plan to use effective contraception during the study and for 6 months after study completion (effective methods include sterilization, intrauterine hormonal devices, condoms, contraceptive pills/agents, abstinence, or partner vasectomy/tubal ligation).
- 8.Pregnant or lactating women.
- 9.Patients with claustrophobia, bipolar disorder, other psychiatric disorders, or poor compliance.
- 10.Patients who participated in another investigational drug clinical study within 30 days prior to enrollment or plan to do so during follow-up.
- 11.Any other condition that, in the opinion of the investigators, makes the patient unsuitable for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Imaging Study of PET Myocardial Perfusion With XTR004 Injection Versus MIBI SPECT in Patients With Borderline Coronary Stenosis
Compare the diagnostic certainty of MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI.
Read the detailed description
This trial is a single-arm, single-center, open-label, self-controlled study. Patients with suspected or known stable coronary artery disease who have previously undergone coronary CTA showing 30%-80% stenosis in any coronary vessel, or mild to moderate stenosis, will be enrolled and sequentially undergo MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI. Imaging will be independently and blindly read by expert readers for both MIBI SPECT MPI and XTR004 PET MPI. The diagnostic certainty of the reading results from the two imaging modalities will then be compared.
- Being tested
- XTR004
- Keywords
- XTR004, MPI, PET, SPECT, diagnostic certainty
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 MPI PET & MIBI SPECT MPI | Experimental | Patients with suspected or known stable coronary artery disease who have previously undergone coronary CTA showing 30%-80% stenosis in any coronary vessel, or mild to moderate stenosis, will be enrolled and sequentially undergo MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI Receives: Drug: XTR004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of vessel-level diagnostic certainty for XTR004 PET/MIBI SPECT myocardial perfusion imaging.
Measured: Day1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start19 Dec 2024
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
Why it stopped: The main objective of this study has been achieved. Following internal discussions, the sponsor has decided to terminate this study early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Perfusion ImagingStudies 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
- 17 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
- NCT07187895
- Sponsor's protocol ID
- STB-XTR004-202
- Status last verified
- Jan 2026
- First submitted
- 16 Sep 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Imaging Study of PET Myocardial Perfusion With XTR004 Injection Versus MIBI SPECT in Patients With Borderline Coronary Stenosis
- ClinicalTrials.gov ID
- NCT07187895
- Acronym / sponsor ID
- STB-XTR004-202
- Keywords
- XTR004, MPI, PET, SPECT, diagnostic certainty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The main objective of this study has been achieved. Following internal discussions, the sponsor has decided to terminate this study early.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 23 Sep 2025 (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.
Compare the diagnostic certainty of MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI.
Detailed description
This trial is a single-arm, single-center, open-label, self-controlled study. Patients with suspected or known stable coronary artery disease who have previously undergone coronary CTA showing 30%-80% stenosis in any coronary vessel, or mild to moderate stenosis, will be enrolled and sequentially undergo MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI. Imaging will be independently and blindly read by expert readers for both MIBI SPECT MPI and XTR004 PET MPI. The diagnostic certainty of the reading results from the two imaging modalities will then be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XTR004 MPI PET & MIBI SPECT MPI | Experimental | Drug: XTR004Patients with suspected or known stable coronary artery disease who have previously undergone coronary CTA showing 30%-80% stenosis in any coronary vessel, or mild to moderate stenosis, will be enrolled and sequentially undergo MIBI SPECT myocardial perfusion imaging (MPI) and XTR004 PET MPI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1.Male or female participants aged 18 years or older.
- 2.Suspected or known stable coronary artery disease with related symptoms and stable condition, and having at least one coronary artery disease risk factor, including: hypertension, hyperlipidemia, diabetes, obesity, alcohol abuse, smoking, family history of coronary artery disease, postmenopausal status in women, or advanced age.
- 3.Underwent coronary CTA within the past 6 months showing 30%-90% stenosis, or indicating mild to moderate-to-severe stenosis.
- 4.Able to communicate effectively with the investigators, understand and comply with the clinical study requirements, voluntarily participate in the study, and provide written informed consent.
Key exclusion criteria (11 listed)
- 1. Patients with a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
- 2.Patients with a prior diagnosis of myocardial infarction, congenital heart disease, cardiomyopathy, myocarditis, or other cardiac diseases.
- 3.Patients known to have severe allergic reactions to alcohol.
- 4.Patients known to have an allergy or other contraindications to adenosine.
- 5.Patients known to be allergic to iodinated contrast agents.
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 MPI PET & MIBI SPECT MPI |
Primary outcome
Percentage of vessel-level diagnostic certainty for XTR004 PET/MIBI SPECT myocardial perfusion imaging.
Time frame: Day1-7
Results and safety
The study was stopped early (reason given: The main objective of this study has been achieved. Following internal discussions, the sponsor has decided to terminate this study early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site 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 Myocardial Perfusion Imaging and Diagnostic Certainty, run by Sinotau Pharmaceutical Group at 1 site 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: The main objective of this study has been achieved. Following internal discussions, the sponsor has decided to terminate this study early.). Results are not available in the source record.
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?
Percentage of vessel-level diagnostic certainty for XTR004 PET/MIBI SPECT myocardial perfusion imaging. (time frame: Day1-7). 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 12 Jan 2026.