68Ga-labeled NY108 PET Imaging in Patients

November 27, 2022 updated by: Chunjing Yu, Affiliated Hospital of Jiangnan University
This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY108 (68Ga-NY108) PET Imaging in patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Wuxi, Jiangsu, China, 214000
        • Recruiting
        • Affiliated Hospital of Jiangnan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Patients voluntarily signed informed consent;
  2. Age 18-75, male;
  3. Patients diagnosed with prostatic cancer confirmed by histopathology or cytology;
  4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
  5. Patients with biopsy-proven PSMA positive;
  6. ECOG score 0~3; Life expectancy of at least 3 months;

Exclusion Criteria:

  1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
  2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
  3. Patients with allergies or allergies to any component of the imaging agent or antibody;
  4. Patients who cannot perform PET/CT imaging scan;
  5. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
  6. Patients with autoimmune diseases, including rheumatoid arthritis; Inadequate control of arrhythmias, including atrial fibrillation;
  7. Uncontrolled hypertension;
  8. Syphilis, HBV, HCV, or HIV positive subjects;
  9. Male subjects of reproductive age cannot take effective contraceptive measures;
  10. Patients with a history of mental illness or related conditions;
  11. Other subjects considered unsuitable by researchers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-Anti-PSMA mAbs
Drug: 68Ga-labeled NY108
Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY108.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of tissue distribution of 68Ga-Anti-PSMA mAbs(NY108)
Time Frame: 1 year
Biodistribution of 68Ga-Anti-PSMA mAbs(NY108) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 1 year
Safety will be assessed by evaluation of incidence of adverse events.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Jiangnan University

Investigators

  • Principal Investigator: Chunjing Yu, Affiliated Hospital of Jiangnan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 27, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LS2020005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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