standard-of-care imaging 68Ga-MY6349 and 68Ga-PSMA-11
standard-of-care imaging 68Ga-MY6349 and 68Ga-PSMA-11: Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceuticals 68Ga-MY6349 and 68Ga-PSMA-11, and undergoes PET/CT imaging within the specified time.
Study summary
The main objective of this research is to develop and evaluate new PET imaging agents with high sensitivity and specificity for prostate cancer and other aggressive tumors. Specifically, the research focuses on improving upon existing prostate cancer imaging methods, such as PSA tests and PSMA PET/CT, which have limitations in sensitivity, specificity, and the ability to provide comprehensive tumor information，and aims to create a novel PET probe targeting Trop2, an antigen highly expressed in multiple cancer types, to enable in vivo, whole-tumor assessment. This would support early diagnosis, more precise staging, and effective monitoring of cancer therapy.
Eligibility
Sex
MALE
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Diagnostic accuracy — 2 years The sensitivity, specificity, and accuracy of 68Ga-MY6349 and 68Ga-PSMA-1PET/CT were calculated and compared to evaluate the diagnostic accuracy.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Xiamen University
Xiamen
Fujian
Recruiting
More The First Affiliated Hospital of Xiamen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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