Clinical trial Recruiting at 1 site Observational Ages 18 and up

68Ga-MY6349 PET/CT to detect Trop-2 in solid tumors

Official title: 68Ga-MY6349 PET/CT in Solid Tumors and Compared With 18F-FDG PET/CT

Run by The First Affiliated Hospital of Xiamen University · NCT07046702 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorThe First Affiliated Hospital of Xiamen University
Academic / other
Locations1 site (Xiamen, Fujian)
StatusRecruiting
StartedDecember 10, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJuly 15, 2025
Trial IDNCT07046702 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • The First Affiliated Hospital of Xiamen University
    Xiamen, Fujian, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.