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OpenTrials
Completed

NCT Number: NCT06389695

Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM032 in Patients

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

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Key information

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Affliated Hospital of Jiangnan University, Wuxi, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Planned androgen deprivation therapies use, any therapeutic intervention for the prostate cancer and use of folate supplements during the study;
  • 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;
  • Patients with active infections during screening;
  • 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.

Treatment and study plan

68Ga-NYM032 injection

Drug

The radiation dose is about 3-6 mCi for a single patient.Using a syringe to withdraw 68Ga-NYM032 injection, the dose will be administered via an intravenous injection and the injection time will be about 45-60 seconds.

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Norroy Bioscience Co., LTD

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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