Clinical trial · Interventional
68Ga-labeled NY104 PET Imaging in Patients
NCT05638256CI-TRIAL-00062528unknownEarly 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 NY104 PET Imaging in patients with Renal Cell Carcinoma
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NY104 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NY104
- interventionNames
- Drug: 68Ga-NY104
Primary outcomes (1)
- measure
- Evaluation of tissue distribution of 68Ga-NY104
- timeFrame
- 1 year
- description
- Biodistribution of 68Ga-NY104 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.
Eligibility
Eligibility (as posted)
- Sex
- All
- 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 or female; 3. Patients diagnosed with renal cell carcinoma confirmed by histopathology or cytology; 4. At least one measurable solid lesion has been examined according RECIST1.1 standard; 5. 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 abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines; 4. Patients with autoimmune diseases, including rheumatoid arthritis; 5. Inadequate control of arrhythmias, including atrial fibrillation; 6. Uncontrolled hypertension; 7. Patients with allergies or allergies to any component of the imaging agent or antibody; 8. Patients who cannot undergo PET/CT imaging scan; 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 (1)
- DERIVEDLou K, Wang J, He H, Wang Y, Mi Y, Li W, Chen L, Zhang Y, Mao Y, Lin J, Fu H, Yu C. Value of [68Ga]Ga-NYM046 PET/CT, in Comparison with 18F-FDG PET/CT, for Diagnosis of Clear Cell Renal Cell Carcinoma. J Nucl Med. 2024 Dec 3;65(12):1884-1890. doi: 10.2967/jnumed.124.267527. PMID 39542699