The First Affiliated Hospital of Xiamen University
Phase
Observational
Started
2024-12-10
Last updated
2025-07-15
Condition(s) studied
Solid TumorTrop2PET/CT
Investigational drug(s) / intervention(s)
68Ga-MY6349
68Ga-MY6349: Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.
Study summary
The objective of the study is to construct a noninvasive approach 68Ga-MY6349 PET/CT to detect the Trop-2 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from Trop-2 PET/CT.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* adult patients (aged 18 years or older)
* patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report)
* patients who had scheduled both standard-of-care imaging and 68Ga-MY6349 PET/CT scans
* 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
Exclusion Criteria:
* patients with pregnancy
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
Primary outcome measure(s)
Evaluate the feasibility of PET/CT imaging with 68Ga-MY6349 for the non-invasive assessment of Trop2 expression in various cancer types. — 1 week Tumor Trop2 expression analysis in a fresh biopsy sample will be correlated to 68Ga-MY6349 tumor uptake, evaluated by measuring standardized uptake value (SUV) on the 68Ga-MY6349 PET/CT.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Xiamen University
Xiamen
Fujian
Recruiting
More The First Affiliated Hospital of Xiamen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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