Actively Recruiting
Effect of 68Ga-NY104 and 18F-FDG PET/CT Guided Radiation Therapy Combined with Systemic Treatment in Patients with Clear Cell Renal Cell Carcinoma
Led by Peking Union Medical College Hospital · Updated on 2024-09-27
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
P
Peking University First Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of 68Ga-NY104 and 18F-FDG PET/CT guided radiation therapy with standard systemic treatment in patients who have metastatic clear cell renal cell carcinoma (ccRCC). This phase 2 study focuses on improving treatment outcomes by targeting metastatic lesions more precisely using advanced imaging techniques. The biomarker CAIX, targeted by 68Ga-NY104, has shown promise in detecting ccRCC lesions effectively. Participants will receive radiation therapy planned to cover as many metastatic lesions as possible, guided by baseline PET/CT scans using both 68Ga-NY104 and 18F-FDG. Systemic therapy, which may include targeted therapy, immunotherapy, or both, will be given concurrently and determined by the treating urology oncologist. Follow-up 68Ga-NY104 PET/CT scans will be done at 6, 12, and 24 months if the tumor is controlled, with additional scans as needed for suspected recurrence. During the study, patients will undergo multiple PET/CT scans and other imaging to assess lesion uptake and detection. Researchers will monitor progression-free survival, disease control, overall survival, and adverse events over four years after treatment starts. The study tracks tumor response and safety outcomes while patients continue systemic therapy, with active follow-up for disease status and imaging assessments throughout the trial period.
CONDITIONS
Brief Title
68Ga-NY104 PET/CT Guided Radiation Therapy in CcRCC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed clear cell renal cell carcinoma
- Eligible for radiation therapy with no more than 10 lesions in total
- Expected survival over 3 months
- ECOG performance status 0 or 1
- Sufficient organ function
- Provided written informed consent
You will not qualify if you...
- Brain metastasis or carcinomatous meningitis
- Other malignant tumors not controlled within 5 years, except non-metastatic low-risk prostate cancer
- Pregnant or breastfeeding
- Active infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From start of radiation therapy up to 4 years
Participants receive baseline 68Ga-NY104 and 18F-FDG PET/CT scans to identify metastatic lesions. Radiation therapy is delivered to cover as many metastases as possible, alongside systemic therapy including targeted therapy and/or immunotherapy based on oncologist decisions.
Baseline imaging visits and ongoing treatment sessions as scheduled by the clinical team
Duration - Up to 4 years after treatment
Participants undergo follow-up 68Ga-NY104 PET/CT scans at 6, 12, and 24 months after radiation therapy if the tumor is controlled, and 18F-FDG PET/CT at 6 months. Additional imaging may be performed if recurrence or metastasis is suspected. Disease status is monitored for up to 4 years.
Imaging visits at 6, 12, and 24 months plus additional visits as needed
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
X
Xianshu Gao, MD
M
Mingwei Ma, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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