Clinical trial · Interventional
68Ga-NY104 PET/CT Imaging in Renal Cell Carcinoma
68Ga-NY104 PET/CT Imaging in Patients With Confirmed or Suspicious Renal Cell Carcinoma
NCT05902377CI-TRIAL-00067193unknownPhase 2ClinicalTrials.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 prospective, single-center study in patients with renal cell carcinoma. The goal is to determine the sensitivity and specificity of 68Ga-NY104 PET/CT in the detection of clear cell 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 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NY104 PET/CT
- description
- Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed.
- interventionNames
- Diagnostic Test: 68Ga-NY104 PET/CT
Primary outcomes (1)
- measure
- Binary reading of focal lesions identified on 68Ga-NY104 PET/CT
- timeFrame
- From study completion to 1 month after completion
- description
- Define lesion as PET positive or PET negative lesion.
Secondary outcomes (1)
- measure
- SUVmax of focal lesions identified on 68Ga-NY104 PET/CT
- timeFrame
- From study completion to 1 month after completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent provided for participation in the trial 2. Age ≥ 18 y 3. at least one of the following indications should be applied 1. Scheduled for surgical resection of renal mass 2. confirmed recurrent/metastatic clear cell renal cell carcinoma 3. suspicion for recurrent/metastatic clear cell renal cell carcinoma Exclusion Criteria: 1. On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. 2. Pregnancy or lactation 3. Severe claustrophobia.
References
Publications (1)
- DERIVEDZhu W, Zheng G, Yan X, Liu M, Li X, Cheng Y, Bai C, Zhang Y, Huo L. Diagnostic efficacy of [68Ga]Ga-NY104 PET/CT to identify clear cell renal cell carcinoma. Eur J Nucl Med Mol Imaging. 2024 Nov;51(13):4127-4133. doi: 10.1007/s00259-024-06801-y. Epub 2024 Jun 25. PMID 38916753