NCT06389695CompletedPhase 1/2
Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM032 in Patients
Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of a Single Dose of Gallium [68Ga]-NYM032 Injection Prepared by Kit for the Preparation of the 68Ga-NYM032 Injection in Patients With Prostate Cancer
Source: ClinicalTrials.gov · Last updated 21 May 2025
Brief summary (registry, in English)
68Ga-NYM032 is a PSMA-targeting small-molecular radiotracer for PET/CT imaging of prostate cancer, which is needed for clinical trial to be conducted
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 24 Apr 2024
- Start date
- 4 Jun 2024
- Primary completion date
- 28 Oct 2024
- Lead sponsor
- Norroy Bioscience Co., LTD
- Diseases
- Prostate cancer
- NCT number
- NCT06389695
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 20
- From 4 Jun 2024 to the primary completion date, 28 Oct 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known or suspected to be allergic to the investigational drug or any of its components;
- Accepting other investigational drugs upon enrollment, or within 5 biological half-lives of the drug at enrollment, or within 30 days after its last administration, whichever is longer;
- Those who have used any radioactive therapy medication within 90 days before investigational drug administration, or have received any radioactive diagnostic medication within 3 days before investigational drug administration;
- Plan to arrange surgery and other invasive interventions within 2 days after the injection of the investigational drug;
- Ongoing toxicity \>grade l from previous standard or investigational therapies;
Other illness
- Planned androgen deprivation therapies use, any therapeutic intervention for the prostate cancer and use of folate supplements during the study;
- Patients with active infections during screening;
Other
- Those who have no guarantee of being able to lie down quietly in the examination cabin during a PET examination, or those who suffer from claustrophobia and cannot cooperate in a PET examination:
- Other situations where the researchers believe that the subject is not suitable for inclusion in this study.
Who the study is looking for
- Patients with pathologically confirmed prostate cancer;
- Age range from 18 to 75 years old (including 18 and 75 years old);
- ECOG score of 0 or 1;
- Expected life ≥ 6 months;
- The subjects agree to take effective contraceptive measures during the study period and for at least three months after the diug administration;
- The subjects are able to maintain good communication with the researchers;understand and follow the requirements of this study and sign an informed consent form before the start of relevant research operations.
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Affliated Hospital of Jiangnan University Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.