Effect of 68Ga-NY104 and 18F-FDG PET/CT Guided Radiation Therapy Combined with Systemic Treatment in Patients with Clear Cell Renal Cell Carcinoma.

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Xianshu Gao, MD
gao7777@139.com
+86 01083575641
Backup
Mingwei Ma, MD
dr.mingweima@stu.pku.edu.cn
+86 0108372408
Time Frame
Start Date: 2024-03-27
Estimated Completion Date: 2028-09
Participants
Target number of participants: 40
Treatments
Experimental: NY104 and FDG guided RT combining 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.
Related Therapeutic Areas
Sponsors
Collaborators: Peking University First Hospital
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov