Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
Recruiting · NCT07615101 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
68-Ga-NYM032
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
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.
- \. 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.
Where it is running
2 locations listed.
- Affiliated Drum Tower Hospital, Medical School of Nanjing University - Nanjing, Jiangsu, China
- Affiliated Hospital of Jiangnan University - Wuxi, Jiangsu, China