Evaluating a new PET imaging agent for prostate cancer diagnosis
A Multicenter Study Evaluating the Diagnostic Value of 68Ga-MY6349 PET/CT for Prostate Cancer
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT06696326 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men with an initial diagnosis of prostate cancer or those experiencing biochemical recurrence after treatment.
Not a fit: Patients who are unable to tolerate intravenous administration or have severe comorbid conditions may not benefit from this study.
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 performed: Other studies have shown promise with PET imaging agents targeting specific antigens, suggesting potential for success in this novel approach.
Eligibility criteria
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 this trial is running
Xiamen, Fujian
- 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
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.