Clinical trial · Interventional
Safety Study of 89Zr-NY001 PET Imaging in Patients
Safety Study of 89Zr-NY001 PET Imaging in Patients With Fibronectin ED-B Positive Solid Tumors
NCT04971369CI-TRIAL-00052924unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr-NY001 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 89Zr-NY001 injection
- description
- Patients will receive a tracer (5 mg, IV) dose of Zr-89 (1.5-2 mCi) labeled NY001 (89Zr-NY001)
- interventionNames
- Diagnostic Test: 89Zr-NY001
Primary outcomes (1)
- measure
- Focal lesion of 89Zr-NY001 PET scanning in patients with fibronectin ED-B domain positive solid tumors.
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.