68Ga-NY104 PET/CT Guided Radiation Therapy in CcRCC.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT06613269
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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 our team has shown excellent diagnostic efficacy of 68Ga-NY104, a CAIX-targeted PET tracer, in patients with metastatic ccRCC. In this study, we aim to investigate the effect of 68Ga-NY104, and 18F-FDG PET/CT guided RT combining standard systemic therapy in patients with metastatic ccRCC.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NY104 and FDG guided RT combining systemic therapy 68Ga-NY104 PET/CT 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. NY104 and FDG guided RT combining systemic therapy 18F-FDG PET/CT 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. NY104 and FDG guided RT combining systemic therapy Radiation Therapy 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. NY104 and FDG guided RT combining systemic therapy Systemic therapy 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.
- Primary Outcome Measures
Name Time Method Progression free survival 2, PFS2 the time from the start of RT to 4 years after treatment 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.
- Secondary Outcome Measures
Name Time Method Lesion uptake on 68Ga-NY104 PET/CT From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT Lesion uptake on 18F-FDG PET/CT From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT Number of positive lesions detected on 68Ga-NY104 PET/CT From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT Number of positive lesions detected on 18F-FDG PET/CT From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT Number of lesions detected combining all available imaging modalities From the start of any imaging modality to 1 week after completion of all imaging modalities Objective response rate the time from the start of RT to 4 years after treatment The percentage of patients with complete remission or partial remission of tumor after treatment.
Progression free survival 1, PFS1 the time from the start of RT to 4 years after treatment Progression Free Survival 1 (PFS1) was defined as the time from the beginning of treatment to the emergence of new lesions or the progression of original lesions.
Disease control rate the time from the start of RT to 4 years after treatment The percentage of patients with complete remission, partial remission, or stable disease after treatment.
Overall survival the time from the start of RT to 4 years after treatment Adverse event the time from the start of RT to 4 years after treatment The adverse event due to PET/CT and treatment will be recorded according to CTCAE 5.0.