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

NCT06696326 | Recruiting

• 1 other identifier: XMYY-2024KY171
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Positron-Emission Tomography(PET); Prostate Cancer; Trophoblast Cell Surface Antigen 2

Outcome Measures

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.

  2 years

Secondary Outcomes (2)

• Number of lesions

  2 years

• SUV

  2 years

Study Arms (1)

68Ga-MY6349

EXPERIMENTAL

Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.

Diagnostic Test: standard-of-care imaging 68Ga-MY6349 and 68Ga-PSMA-11

Interventions

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.

68Ga-MY6349

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Other conditions that researchers deem unsuitable for participation in the study.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Chen Haojun, MD, PhD

CONTACT

+8618659285282; leochen0821@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 20, 2024
• Study Start: October 1, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)