68Ga-labeled NY108 PET Imaging in Patients

NCT05623878 | Unknown Early Phase 1

• 1 other identifier: LS2020005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  1 year

Study Arms (1)

68Ga-Anti-PSMA mAbs

EXPERIMENTAL

Drug: 68Ga-labeled NY108

Interventions

68Ga-labeled NY108 DRUG

Patients will receive a tracer (20-40mcg, IV) dose of 68Ga (2-5mCi) labelled NY108.

68Ga-Anti-PSMA mAbs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

RECRUITING

Related Publications (1)

• Fu H, Lou K, He H, Wang Y, Mi Y, Li W, Chen L, Zhang Y, Yu C. A novel PSMA targeted dual-function near-infrared fluorescence and PET probe for the image-guided surgery and detection of prostate cancer. Eur J Nucl Med Mol Imaging. 2024 Aug;51(10):2998-3008. doi: 10.1007/s00259-023-06492-x. Epub 2023 Nov 2.

  PMID: 37914976 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Chunjing Yu

  Affiliated Hospital of Jiangnan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunjing Yu

CONTACT

15312238622; ycj_wxd1978@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 21, 2022
• Study Start: January 4, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)