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NCT07615101
Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
Conditions: Prostate Cancer (Diagnosis)
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 365
Sponsor: Norroy Bioscience Co., LTD
Location: Affiliated Drum Tower Hospital, Medical School of Nanjing University Nanjing Jiangsu
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 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.
Source: ClinicalTrials.gov (NCT07615101). StuddyBuddy aggregates publicly available trial information.