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
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
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)
- sensitivity and specificity — up to 30 days
Assessing the sensitivity and specificity of 68Ga-NYM032 Injection positron emission tomography (PET) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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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