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68Ga-labeled NY108 PET Imaging in Patients

Sponsor
Affiliated Hospital of Jiangnan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05623878
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
22.9
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY108 (68Ga-NY108) PET Imaging in patients.

Condition or Disease Intervention/Treatment Phase
  • Drug: 68Ga-labeled NY108
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
68Ga-labeled NY108 PET Imaging in Patients
Actual Study Start Date :
Jan 4, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of tissue distribution of 68Ga-Anti-PSMA mAbs(NY108) [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.

Secondary Outcome Measures

  1. Incidence of Treatment-Emergent Adverse Events [1 year]

    Safety will be assessed by evaluation of incidence of adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated Hospital of Jiangnan University Wuxi Jiangsu China 214000

Sponsors and Collaborators

  • Affiliated Hospital of Jiangnan University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chunjing Yu, Director, Affiliated Hospital of Jiangnan University
ClinicalTrials.gov Identifier:
NCT05623878
Other Study ID Numbers:
  • LS2020005
First Posted:
Nov 21, 2022
Last Update Posted:
Dec 1, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Dec 1, 2022