68Ga-MY6349 PET/CT to detect Trop-2 in solid tumors
68Ga-MY6349 PET/CT in Solid Tumors and Compared With 18F-FDG PET/CT
The First Affiliated Hospital of Xiamen University · NCT07046702
This scan will see if a new 68Ga-MY6349 PET/CT can detect Trop‑2 on tumors in adults with solid tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University (other) |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT07046702 on ClinicalTrials.gov |
What this trial studies
68Ga-MY6349 is a new PET radiotracer that targets Trop‑2, a cell-surface protein expressed by many solid tumors. Adult participants with suspected, newly diagnosed, or previously treated solid tumors will undergo contemporaneous 68Ga-MY6349 and standard-of-care 18F-FDG PET/CT for initial staging or recurrence detection. Tumor uptake will be quantified by SUVmax and lesions will be recorded by visual interpretation to count positive findings on each imaging method. The diagnostic accuracy of 68Ga-MY6349 will be calculated and compared directly to standard imaging to see if it reliably identifies Trop‑2 expression.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with suspected, newly diagnosed, or previously treated malignant solid tumors who are scheduled for both standard-of-care imaging and 68Ga-MY6349 PET/CT and can provide informed consent.
Not a fit: Patients who are pregnant, unable or unwilling to provide informed consent, or whose tumors do not express Trop‑2 are unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, this imaging could noninvasively identify Trop‑2–positive tumors and help select patients for Trop‑2–targeted therapies or clinical trials.
How similar studies have performed: Trop‑2 is an established therapeutic target and early imaging work and Trop‑2–directed therapies support the approach, but clinical data specifically for 68Ga-MY6349 PET/CT are limited and remain exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Xiamen, Fujian
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (RECRUITING)
Study contacts
- Study coordinator: Liang Zhao, MD, PhD
- Email: wzhaoliang01@163.com
- Phone: 86 18818350620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumor, Trop2, PET/CT, Solid tumor