Clinical trial NCT06613269: 68Ga-NY104 PET/CT Guided Radiation Therapy in CcRCC.
Official title: Effect of 68Ga-NY104 and 18F-FDG PET/CT Guided Radiation Therapy Combined with Systemic Treatment in Patients with Clear Cell Renal Cell Carcinoma.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Clear Cell Renal Cell Carcinoma
Keywords: clear cell renal cell carcinoma
CAIX
radiation therapy
68Ga-NY104
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
First posted: 2024-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival 2, PFS2
timeFrame: the time from the start of RT to 4 years after treatment
Secondary outcomes:
measure: Lesion uptake on 68Ga-NY104 PET/CT
timeFrame: From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT
measure: Lesion uptake on 18F-FDG PET/CT
timeFrame: From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT
measure: Number of positive lesions detected on 68Ga-NY104 PET/CT
timeFrame: From the start of 68Ga-NY104 PET/CT to 1 week after the 68Ga-NY104 PET/CT
measure: Number of positive lesions detected on 18F-FDG PET/CT
timeFrame: From the start of 18F-FDG PET/CT to 1 week after the 18F-FDG PET/CT
measure: Number of lesions detected combining all available imaging modalities
timeFrame: From the start of any imaging modality to 1 week after completion of all imaging modalities
measure: Objective response rate
timeFrame: the time from the start of RT to 4 years after treatment
measure: Progression free survival 1, PFS1
timeFrame: the time from the start of RT to 4 years after treatment
measure: Disease control rate
timeFrame: the time from the start of RT to 4 years after treatment
measure: Overall survival
timeFrame: the time from the start of RT to 4 years after treatment
measure: Adverse event
timeFrame: the time from the start of RT to 4 years after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References: