Clinical trial · Interventional
68Ga-labeled NY108 PET Imaging in Patients
NCT05623878CI-TRIAL-00062440unknownEarly Phase 1ClinicalTrials.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 68Ga-labeled NY108 (68Ga-NY108) PET Imaging in patients.
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 |
|---|---|---|---|
| Prostatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-labeled NY108 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-Anti-PSMA mAbs
- interventionNames
- Drug: 68Ga-labeled NY108
Primary outcomes (1)
- measure
- Evaluation of tissue distribution of 68Ga-Anti-PSMA mAbs(NY108)
- timeFrame
- 1 year
- description
- 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.
Secondary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- 1 year
- description
- Safety will be assessed by evaluation of incidence of adverse events.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients voluntarily signed informed consent; 2. Age 18-75, male; 3. Patients diagnosed with prostatic cancer confirmed by histopathology or cytology; 4. At least one measurable solid lesion has been examined according RECIST1.1 standard; 5. Patients with biopsy-proven PSMA positive; 6. ECOG score 0\~3; Life expectancy of at least 3 months; 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; Inadequate control of arrhythmias, including atrial fibrillation; 7. Uncontrolled hypertension; 8. Syphilis, HBV, HCV, or HIV positive subjects; 9. Male subjects of reproductive age cannot take effective contraceptive measures; 10. Patients with a history of mental illness or related conditions; 11. Other subjects considered unsuitable by researchers.
References
Publications (1)
- DERIVEDFu 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