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Clinical Trials in China / NCT07615101
Recruiting Phase 3

Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.

NCT07615101 · tracked via the Priya Life Science China tracker
Sponsor
Norroy Bioscience Co., LTD
Phase
Phase 3
Started
2026-08-06
Last updated
2026-08-17

Condition(s) studied

Prostate Cancer (Diagnosis)

Investigational drug(s) / intervention(s)

68-Ga-NYM032

68-Ga-NYM032: IV injection

Study summary

The investigators are imaging patients with newly diagnosed prostate cancer using a new Positron Emission Tomography (PET) imaging agent (68Ga-NYM032) in order to evaluate the safety and diagnostic performance.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Patient is male and aged \>18 years old. 2. Biopsy proven prostate adenocarcinoma. 3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND). 4. ECOG performance status 0-2; expected survival ≥ 6 months. 6\. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: * 1\. Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection. 2\. Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection. 3\. Known hypersensitivity to the active ingredient or excipients of the study drug. 4\. Participants not capable of getting PET study , or inability to lay still for the duration of the exam. 5\. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Affiliated Drum Tower Hospital, Medical School of Nanjing University Nanjing Jiangsu Recruiting
Affiliated Hospital of Jiangnan University Wuxi Jiangsu Recruiting

More Norroy Bioscience Co., LTD trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07615101 on ClinicalTrials.gov ↗ ← All trials in China