What is 68Ga-MY6349 studying for prostate cancer?

68Ga-MY6349 is being studied to improve imaging for prostate cancer by targeting a protein called Trop2 found on many tumors. Researchers aim to enhance early diagnosis, staging, and monitoring of cancer treatment compared to current imaging methods. This research is sponsored by The First Affiliated Hospital of Xiamen University.

Who may be eligible for this prostate cancer clinical trial?

Men aged 18 to 90 years diagnosed with prostate cancer or experiencing biochemical recurrence after prostate surgery or radiotherapy may be eligible. Participants must have an expected survival time over 3 months and be able to tolerate intravenous injections. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the imaging tracer and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 90Years

MALE

ID06696326

A Multicenter Study Evaluating the Diagnostic Value of 68Ga-MY6349 PETCT for Prostate Cancer

Led by The First Affiliated Hospital of Xiamen University · Updated on 2024-12-18

100

Participants Needed

Research Sites

N/A

Total Duration

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 PETCT, 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 PETCT 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 PETCT 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

Age: 18Years - 90Years

MALE

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.

Research Team

Chen Haojun, MD, PhD

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