Safety Study of 89Zr-NY001 PET Imaging in Patients

NCT04971369 | Unknown

• 1 other identifier: Wuxi-4 PH NY001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY001 (89Zr-NY001) PET imaging in patients with fibronectin ED-B domain positive solid tumors.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• Focal lesion of 89Zr-NY001 PET scanning in patients with fibronectin ED-B domain positive solid tumors.

  Degree and localization of focal lesion compared with that of 18F-FDG PET scans and according to the expression of fibronectin ED-B domain will be reported.

  1 year

Study Arms (1)

89Zr-NY001 injection

EXPERIMENTAL

Patients will receive a tracer (5 mg, IV) dose of Zr-89 (1.5-2 mCi) labeled NY001 (89Zr-NY001)

Diagnostic Test: 89Zr-NY001

Interventions

89Zr-NY001 DIAGNOSTIC_TEST

89Zr-NY001 injection followed by 89Zr-NY001 PET scan

89Zr-NY001 injection

Eligibility Criteria

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

You may qualify if:

• Patients voluntarily signed informed consent;
• Aged \>18, male or female;
• Patients diagnosed with solid tumors confirmed by histopathology or cytology test;
• At least two measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
• Patients with biopsy-proven fibronectin ED-B positive;
• ECOG score ≤ 0\~3; Life expectancy of at least 3 months;
• Women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects;
• ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit;
• Other routine examinations are within the normal range or considered acceptable by the researchers.

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 and female subjects of reproductive age cannot take effective contraceptive measures;
• Pregnant or lactating women;
• Patients with a history of mental illness or related conditions;
• Other subjects considered unsuitable by researchers.

Sponsors & Collaborators

• Wuxi No. 4 People's Hospital: lead

Study Sites (1)

Wuxi No. 4 People's Hospital

Wuxi, Jiangsu, 214062, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 21, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)