Clinical trial Recruiting at 1 site Interventional Ages 18 to 90 Men only

Evaluating a new PET imaging agent for prostate cancer diagnosis

Official title: A Multicenter Study Evaluating the Diagnostic Value of 68Ga-MY6349 PET/CT for Prostate Cancer

Run by The First Affiliated Hospital of Xiamen University · NCT06696326 · Data updated 2026-11-12

This study is testing a new imaging agent for prostate cancer to see if it can help doctors find and monitor the disease more accurately than current methods.

Quick facts

Study typeInterventional
Ages18 Years to 90 Years
SexMen only
Enrollment100 (estimated)
SponsorThe First Affiliated Hospital of Xiamen University
Academic / other
Drugs / interventionsradiation
Locations1 site (Xiamen, Fujian)
StatusRecruiting
StartedOctober 1, 2024
Main results expectedOctober 15, 2025
Study endsOctober 15, 2025
Registry record updatedDecember 18, 2024
Trial IDNCT06696326 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men with an initial diagnosis of prostate cancer or those experiencing biochemical recurrence after treatment.

Probably not a fit

Patients who are unable to tolerate intravenous administration or have severe comorbid conditions may not benefit from this study.

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

What this trial studies

This study aims to develop and assess a novel PET imaging agent, 68Ga-MY6349, which targets the Trop2 antigen, highly expressed in prostate cancer and other aggressive tumors. The research seeks to improve existing imaging methods, such as PSA tests and PSMA PET/CT, by providing enhanced sensitivity and specificity for early diagnosis, accurate staging, and effective monitoring of cancer therapy. Participants will undergo standard-of-care imaging with both 68Ga-MY6349 and 68Ga-PSMA-11 to evaluate the diagnostic value of the new agent compared to existing methods.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and earlier detection of prostate cancer, improving patient outcomes.

How similar studies have gone: Other studies have shown promise with PET imaging agents targeting specific antigens, suggesting potential for success in this novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patients with initial diagnosis of prostate cancer, or patients with biochemical recurrence after radical prostatectomy or radical radiotherapy.
2. Estimated survival time \>3 months, as determined by a physician.
3. Willing to sign the informed consent form voluntarily and able to comply with the study protocol.

Exclusion Criteria:

1. Individuals unable to tolerate intravenous administration (e.g., history of needle or blood phobia).
2. Patients deemed unsuitable by researchers or unable to complete PET or other imaging examinations due to specific conditions, such as claustrophobia or radiophobia.
3. Individuals with occupational exposure to radiation.
4. Patients with severe diseases affecting the heart, kidneys, lungs, vascular, neurological, or mental systems, immune deficiency disorders, or hepatitis/cirrhosis.
5. Other conditions that researchers deem unsuitable for participation in the study.

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.