A Multicenter Study Evaluating the Diagnostic Value of 68Ga-MY6349 PET/CT for Prostate Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-90
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with initial diagnosis of prostate cancer, or patients with biochemical recurrence after radical prostatectomy or radical radiotherapy.

Estimated survival time >3 months, as determined by a physician.

Willing to sign the informed consent form voluntarily and able to comply with the study protocol.

Disqualifiers

Individuals unable to tolerate intravenous administration (e.g., history of needle or blood phobia).

Patients deemed unsuitable by researchers or unable to complete PET or other imaging examinations due to specific conditions, such as claustrophobia or radiophobia.

Individuals with occupational exposure to radiation.

Patients with severe diseases affecting the heart, kidneys, lungs, vascular, neurological, or mental systems, immune deficiency disorders, or hepatitis/cirrhosis.

Trial design

Design model

Single group

Treatments tested in this trial

  • standard-of-care imaging 68Ga-MY6349 and 68Ga-PSMA-11

    Diagnostic test

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: 68Ga-MY6349Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy

The sensitivity, specificity, and accuracy of 68Ga-MY6349 and 68Ga-PSMA-1PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Time frame
2 years

Secondary outcomes

1

Number of lesions

The numbers of positive primary and metastatic lesions of 68-MY6349 PET/CT and 68Ga-PSMA-11 PET/CT were recorded by visual interpretation.

Time frame
2 years
2

SUV

Standardized uptake value (SUV) of 68-MY6349 PET/CT and 68Ga-PSMA-11 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.