Actively Recruiting
A Multicenter Study Evaluating the Diagnostic Value of 68Ga-MY6349 PET/CT for Prostate Cancer
Led by The First Affiliated Hospital of Xiamen University · Updated on 2024-12-18
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new PET imaging agent called 68Ga-MY6349 to improve diagnosis and monitoring of prostate cancer and other aggressive tumors. This study aims to overcome limitations of current methods like PSA tests and PSMA PET/CT, which may miss some tumors or lack detailed tumor information. The new probe targets Trop2, a protein highly expressed in many cancers, to provide a whole-tumor assessment in living patients, supporting earlier diagnosis and better treatment planning. Participants will receive a single injection of the 68Ga-MY6349 tracer followed by PET/CT imaging to visualize cancer presence and activity. This novel agent is compared to existing imaging agents like 68Ga-PSMA-11, with hopes of detecting more lesions and providing more sensitive and specific results. The study involves a single administration and imaging session per participant. During the study, participants undergo PET/CT scans after receiving the tracer to assess tumor detection and uptake. Researchers will measure diagnostic accuracy over two years, including counting the number of lesions and standardized uptake values (SUV) to evaluate tracer performance. The trial includes safety monitoring and requires participant consent and adherence to the imaging protocol, lasting up to two years for outcome evaluation.
CONDITIONS
Brief Title
A Multicenter Study Evaluating the Diagnostic Value of 68Ga-MY6349 PET/CT for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with initial diagnosis of prostate cancer, or patients with biochemical recurrence after radical prostatectomy or radical radiotherapy.
- Estimated survival time greater than 3 months, as determined by a physician.
- Willing to sign the informed consent form voluntarily and able to comply with the study protocol.
You will not qualify if you...
- Individuals unable to tolerate intravenous administration, such as those with needle or blood phobia.
- Patients unable to complete PET or other imaging examinations due to conditions like claustrophobia or radiophobia.
- Individuals with occupational exposure to radiation.
- Patients with severe diseases affecting heart, kidneys, lungs, vascular, neurological, or mental systems, immune deficiency disorders, or hepatitis/cirrhosis.
- Other conditions deemed unsuitable for participation by researchers.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single intravenous injection of 68Ga-MY6349 and 68Ga-PSMA-11 and undergo PET/CT imaging to evaluate prostate cancer presence and characteristics.
1 visit (in-person)
Duration - 2 years
Participants are monitored for diagnostic accuracy outcomes, lesion detection, and SUV measurements over a 2-year period following imaging.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
Research Team
C
Chen Haojun, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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