Safety Study of 89Zr-NY001 PET Imaging in Patients

Overview

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.

Full Title of Study: “Safety Study of 89Zr-NY001 PET Imaging in Patients With Fibronectin ED-B Positive Solid Tumors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

  • Diagnostic Test: 89Zr-NY001
    • 89Zr-NY001 injection followed by 89Zr-NY001 PET scan

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Focal lesion of 89Zr-NY001 PET scanning in patients with fibronectin ED-B domain positive solid tumors.
    • Time Frame: During 1 day scanning
    • We assume focal lesion will be feasible with 89Zr-NY001 PET scanning in patients with fibronectin ED-B domain positive solid tumors. For each 89Zr-NY001 PET scan the amount of focal lesion and the localization will be reported. The focal lesion found on the 89Zr-NY001 PET scan will be compared with focal lesions found on the FDG-PET scan. Furthermore the amount of focal lesion will be compared with the expression of fibronectin ED-B domain.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wuxi No. 4 People’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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