Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

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Source: NCT06696326

Recruiting

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

Prostate Cancer

Phase not listed

The First Affiliated Hospital of Xiamen University

China

Sponsor: The First Affiliated Hospital of Xiamen University

Last Updated: December 18, 2024
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

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Study Type

Diagnostic

Radiation

Positron

Radiopharmaceutical

Ga-68 HBED-iPSMA, Ga-68 MY6349

Target

PSMA, Trop-2

Trial Started

October 1, 2024

Last Updated by Sponsor

December 18, 2024

Estimated Completion

October 15, 2025

Eligibility

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.

Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll100

Arms & Interventions

Arms

Interventions

Type: Experimental

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

Interventions:

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

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy2 years

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

Secondary Outcome Measures

Number of lesions2 years

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

SUV2 years

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.

Trial Sites

This study has 1 trial site

The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, CN

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