Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
Starting soon · Phase 3
Conditions studied: Prostate Cancer (Diagnosis)
In brief
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.
Key facts
- Study ID
- NCT07615101
- Run by
- Norroy Bioscience Co., LTD
- People needed
- 365
- Starts
- 2026-06-01
- Expected to finish
- 2027-07-30
- Last updated by the study team
- 2026-06-01
Who can join
Age: 0 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patient is male and aged >18 years old.
- Biopsy proven prostate adenocarcinoma.
- Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
- ECOG performance status 0-2; expected survival ≥ 6 months.
- Ability to understand a written informed consent document, and the willingness to sign it.
You may not qualify if…
- 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.
- 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.
- Known hypersensitivity to the active ingredient or excipients of the study drug.
- Participants not capable of getting PET study , or inability to lay still for the duration of the exam.
- Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.
Full record on ClinicalTrials.gov
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