Clinical trial · Interventional
68Ga-NY104 PET/CT Guided Radiation Therapy in CcRCC.
Effect of 68Ga-NY104 and 18F-FDG PET/CT Guided Radiation Therapy Combined with Systemic Treatment in Patients with Clear Cell Renal Cell Carcinoma.
- 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)
Radiation therapy (RT) is an effective treatment for patients with advanced-stage clear cell renal cell carcinoma (ccRCC). Current evidence has shown promising outcomes combining radiation therapy and standard systemic therapy in patients with metastatic/recurrent ccRCC. CAIX is a highly sensitive and specific biomarker expressed on ccRCC and in previous studies the investigators have shown excellent diagnostic efficacy of 68Ga-NY104, a CAIX-targeted PET tracer, in patients with metastatic ccRCC. In this study, the investigators aim to investigate the effect of 68Ga-NY104, and 18F-FDG PET/CT guided RT combining standard systemic therapy in patients with metastatic ccRCC.
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 |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG PET/CT | Drug | — | UNRESOLVED |
| 68Ga-NY104 PET/CT | Drug | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Systemic therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NY104 and FDG guided RT combining systemic therapy
- description
- In this arm, patients will undergo baseline evaluation using both 68Ga-NY104 and 18F-FGD PET/CT. Metastatic lesions will be identified based on these two PET/CTs and all other imaging modalities available. The radiation field will be planned to cover as much metastasis as possible if not all. Systemic therapy will be delivered at the same time. The patients will be followed up for disease status.
- interventionNames
- Drug: 68Ga-NY104 PET/CT
- Drug: 18F-FDG PET/CT
- Radiation: Radiation Therapy
- Drug: Systemic therapy
Primary outcomes (1)
- measure
- Progression free survival 2, PFS2
- timeFrame
- the time from the start of RT to 4 years after treatment
- description
- Progression Free Survival 2 (PFS2) was defined as the time from the beginning of treatment to the emergence of new lesions or the progression of original lesions, when the lesions could not be fully covered by radiotherapy, and the drug regimen had to be changed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old * Histologically or cytologically confirmed clear cell renal cell carcinoma * Eligible for radiation therapy: no more than 10 lesions in total * Expected survival: over 3 months * ECOG: 0 or 1 * Sufficient organ function * Written informed consent Exclusion Criteria: * Brain metastasis/carcinomatous meningitis * Other malignant tumors that are not controlled within 5 years, except for non-metastatic low-risk prostate cancer. * Pregnant or breastfeeding. * Active infection.
References
Publications (0)
Data not yet available