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68Ga-labeled NY108 PET Imaging in Patients

Primary Purpose

Prostatic Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-labeled NY108
Sponsored by
Affiliated Hospital of Jiangnan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Patients voluntarily signed informed consent; Age 18-75, male; Patients diagnosed with prostatic cancer confirmed by histopathology or cytology; At least one measurable solid lesion has been examined according RECIST1.1 standard; Patients with biopsy-proven PSMA positive; ECOG score 0~3; Life expectancy of at least 3 months; Exclusion Criteria: Recovery from major trauma (including surgery) within 4 weeks prior to study treatment; Patients with systemic or locally severe infections, or other serious coexisting diseases; Patients with allergies or allergies to any component of the imaging agent or antibody; Patients who cannot perform PET/CT imaging scan; Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines; Patients with autoimmune diseases, including rheumatoid arthritis; Inadequate control of arrhythmias, including atrial fibrillation; Uncontrolled hypertension; Syphilis, HBV, HCV, or HIV positive subjects; Male subjects of reproductive age cannot take effective contraceptive measures; Patients with a history of mental illness or related conditions; Other subjects considered unsuitable by researchers.

Sites / Locations

  • Affiliated Hospital of Jiangnan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-Anti-PSMA mAbs

Arm Description

Outcomes

Primary Outcome Measures

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

Incidence of Treatment-Emergent Adverse Events
Safety will be assessed by evaluation of incidence of adverse events.

Full Information

First Posted
November 15, 2022
Last Updated
November 27, 2022
Sponsor
Affiliated Hospital of Jiangnan University
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1. Study Identification

Unique Protocol Identification Number
NCT05623878
Brief Title
68Ga-labeled NY108 PET Imaging in Patients
Official Title
68Ga-labeled NY108 PET Imaging in Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Jiangnan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-Anti-PSMA mAbs
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
68Ga-labeled NY108
Intervention Description
Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY108.
Primary Outcome Measure Information:
Title
Evaluation of tissue distribution of 68Ga-Anti-PSMA mAbs(NY108)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Safety will be assessed by evaluation of incidence of adverse events.
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients voluntarily signed informed consent; Age 18-75, male; Patients diagnosed with prostatic cancer confirmed by histopathology or cytology; At least one measurable solid lesion has been examined according RECIST1.1 standard; Patients with biopsy-proven PSMA positive; ECOG score 0~3; Life expectancy of at least 3 months; Exclusion Criteria: Recovery from major trauma (including surgery) within 4 weeks prior to study treatment; Patients with systemic or locally severe infections, or other serious coexisting diseases; Patients with allergies or allergies to any component of the imaging agent or antibody; Patients who cannot perform PET/CT imaging scan; Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines; Patients with autoimmune diseases, including rheumatoid arthritis; Inadequate control of arrhythmias, including atrial fibrillation; Uncontrolled hypertension; Syphilis, HBV, HCV, or HIV positive subjects; Male subjects of reproductive age cannot take effective contraceptive measures; Patients with a history of mental illness or related conditions; Other subjects considered unsuitable by researchers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunjing Yu
Phone
15312238622
Email
ycj_wxd1978@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunjing Yu
Organizational Affiliation
Affiliated Hospital of Jiangnan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Jiangnan University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunjing Yu
Phone
15312238622
Email
ycj_wxd1978@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

68Ga-labeled NY108 PET Imaging in Patients

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