About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

(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.

Disqualifiers

(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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

18F/68Ga-GP1
Diagnostic test
Each subject receive a single intravenous injection of 18F/68Ga-GP1, and undergo PET/ CT or MRI imaging within the specificed time.

Treatment groups

500 Participants

are divided into 2 treatment groups

Group A: Healthy participants1 intervention

Group B: Patients with thrombi1 intervention

Trial outcomes

Primary outcomes

1

Standardized uptake value (SUV)

Standardized uptake value (SUV) of 18F/68Ga-GP1 for each target lesion of subject or suspected thrombi.

Time frame

30 days

Secondary outcomes

1

Diagnostic efficacy

The sensitivity, specificity and accuracy of GPIIb/IIIa PET/CT were calculated.