68Ga-NY104 PET/CT Guided Radiation Therapy in CcRCC. (NYCRRT)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Clear Cell Renal Cell Carcinoma

Treatments: Radiation: Radiation Therapy; Drug: Systemic therapy; Drug: 18F-FDG PET/CT; Drug: 68Ga-NY104 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT06613269

2024-413-002

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

NY104 and FDG guided RT combining systemic therapy

Experimental group

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.

Treatment:

Drug: 68Ga-NY104 PET/CT

Drug: 18F-FDG PET/CT

Drug: Systemic therapy

Radiation: Radiation Therapy