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 type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | Men only |
| Enrollment | 100 (estimated) |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Xiamen, Fujian) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | October 15, 2025 |
| Study ends | October 15, 2025 |
| Registry record updated | December 18, 2024 |
| Trial ID | NCT06696326 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
- Study coordinator: Chen Haojun, MD, PhD
- Email: leochen0821@foxmail.com
- Phone: +8618659285282
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.