Safety Study of 89Zr-NY001 PET Imaging in Patients

Not Applicable

• Conditions: Solid Tumor, Adult
• Interventions: Diagnostic Test: 89Zr-NY001

• Registration Number: NCT04971369
• Lead Sponsor: Wuxi No. 4 People's Hospital

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.

Detailed Description

After being fully informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of 89Zr-NY001 and will undergo PET/CT scanning to determine uptake of 89Zr-NY001 in tumor lesions and the whole body.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-21
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-27
• Study Start: 2021-08-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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;
7. Inadequate control of arrhythmias, including atrial fibrillation;
8. Uncontrolled hypertension;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Focal lesion of 89Zr-NY001 PET scanning in patients with fibronectin ED-B domain positive solid tumors.	1 year	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.

Trial Locations

Locations (1)

Wuxi No. 4 People's Hospital; 🇨🇳 Wuxi, Jiangsu, China