ThrombiNCT07813559
Glycoprotein IIb/IIIa PET/CT in Various GPIIb/IIIa-Related Disease
An observational study of Thrombi and Thrombus, Brain, run by Tianjin Medical University at 3 sites in China.
Trial summary
In the field of diagnosing Thrombi diseases, it is now a well established practice to inject positron-emitting tracers into the human body. These tracers bind to specific target proteins, allowing their distribution to be visualized via PET imaging. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombi, Thrombus, Brain, Thrombus
- What is being tested?
- 18F/68Ga-GP1
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2026to 1 Sep 2031
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated thrombi (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled GPIIb/IIIa PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Who may be able to join
- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated thrombi (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled GPIIb/IIIa PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Who cannot join
- (i) patients with non-thrombi lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230000
Qiang Xie, PhD, +8613721108043, ahxq1980@163.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Guangjie Yang, MD, +8617853297979, ygj_2815@qdu.edu.cn
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Haonan Yu, MD, +8613821000597, dreamadam@126.com
About this study
In the field of diagnosing Thrombi diseases, it is now a well established practice to inject positron-emitting tracers into the human body.
These tracers bind to specific target proteins, allowing their distribution to be visualized via PET imaging. Currently, several research groups worldwide are engaged in developing and clinically validating their own GPIIb/IIIa imaging agents.
Read the detailed description
This clinical research project aims to visualize abnormal tau pathology in the living human brain using [18F/68Ga]GP1 PET imaging. [18F/68Ga]GP1 is a small molcule-based tracer that offers stronger binding affinity to GPIIb/IIIa. The study primarily focuses on evaluating the safety and diagnostic efficacy of [18F/68Ga]GP1 PET imaging in human subjects.
- Conditions
- Thrombi, Thrombus, Brain, Thrombus
- Being tested
- 18F/68Ga-GP1
- Keywords
- PET/CT, thrombus, thrombi, GPIIb/IIIa receptors
- Medical subject headings
- Thrombosis, Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F/68Ga-GP1Diagnostic test
Each subject receive a single intravenous injection of 18F/68Ga-GP1, and undergo PET/ CT or MRI imaging within the specificed time.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F/68Ga]GP1 followed by a PET/CT scan. Receives: Diagnostic Test: 18F/68Ga-GP1 | |
| Patients with thrombi | Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F/68Ga]GP1 followed by a PET/CT scan Receives: Diagnostic Test: 18F/68Ga-GP1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value (SUV)
Standardized uptake value (SUV) of 18F/68Ga-GP1 for each target lesion of subject or suspected thrombi.
Measured: 30 days
Secondary outcomes (1)
Diagnostic efficacy
The sensitivity, specificity and accuracy of GPIIb/IIIa PET/CT were calculated.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Sep 2026
- Primary completion1 Sep 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombiStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Responsible party
- Principal investigator, Shaobo Yao, PhD, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813559
- Sponsor's protocol ID
- TJMUGH-18
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycoprotein IIb/IIIa PET/CT in Various GPIIb/IIIa-Related Disease
- ClinicalTrials.gov ID
- NCT07813559
- Acronym / sponsor ID
- TJMUGH-18
- Conditions
- Thrombi, Thrombus, Brain, Thrombus
- Keywords
- PET/CT, thrombus, thrombi, GPIIb/IIIa receptors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 10 Sep 2026 (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.
In the field of diagnosing Thrombi diseases, it is now a well established practice to inject positron-emitting tracers into the human body.
These tracers bind to specific target proteins, allowing their distribution to be visualized via PET imaging. Currently, several research groups worldwide are engaged in developing and clinically validating their own GPIIb/IIIa imaging agents.
Detailed description
This clinical research project aims to visualize abnormal tau pathology in the living human brain using [18F/68Ga]GP1 PET imaging. [18F/68Ga]GP1 is a small molcule-based tracer that offers stronger binding affinity to GPIIb/IIIa. The study primarily focuses on evaluating the safety and diagnostic efficacy of [18F/68Ga]GP1 PET imaging in human subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Diagnostic Test: 18F/68Ga-GP1Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F/68Ga]GP1 followed by a PET/CT scan. |
| Patients with thrombi | – | Diagnostic Test: 18F/68Ga-GP1Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F/68Ga]GP1 followed by a PET/CT scan |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated thrombi (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled GPIIb/IIIa PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Key inclusion criteria (1 listed)
- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated thrombi (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled GPIIb/IIIa PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Key exclusion criteria (1 listed)
- (i) patients with non-thrombi lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
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 |
|---|---|---|
| 18F/68Ga-GP1Each subject receive a single intravenous injection of 18F/68Ga-GP1, and undergo PET/ CT or MRI imaging within the specificed time. | Diagnostic test | Healthy participants, Patients with thrombi |
Primary outcome
Standardized uptake value (SUV)
Time frame: 30 days
Standardized uptake value (SUV) of 18F/68Ga-GP1 for each target lesion of subject or suspected thrombi.
1 secondary outcome
Diagnostic efficacy
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombi and Thrombus, Brain, run by Tianjin Medical University at 3 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haonan Yu, MD (+8613821000597, dreamadam@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value (SUV) (time frame: 30 days). 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 10 Sep 2026.