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

NCT07615101

RecruitingPhase 3

Sponsor: Norroy Bioscience Co., LTD

Conditions: Prostate Cancer (Diagnosis)

Interventions: 68-Ga-NYM032

Countries: China

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (2)

Nanjing, Jiangsu, China
Wuxi, Jiangsu, China