RecruitingPhase 2NCT06613269

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

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


Sponsor

Peking Union Medical College Hospital

Enrollment

40 participants

Start Date

Mar 27, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special PET scan tracer (68Ga-NY104) to guide radiation therapy in people with clear cell renal cell carcinoma (a type of kidney cancer). The tracer helps doctors identify and target tumor lesions more precisely with radiation. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with clear cell renal cell carcinoma (confirmed by biopsy or pathology) - You have 10 or fewer tumor lesions and are eligible for radiation therapy - You are in good physical health (ECOG 0–1) with expected survival over 3 months **You may NOT be eligible if...** - You have more than 10 tumor lesions - You have poor organ function (kidney, liver, blood counts) - You are pregnant or breastfeeding - You have had recent surgery or radiation that would interfere Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG68Ga-NY104 PET/CT

68Ga-NY104 PET/CT will be performed at baseline, 6 months, 12 months, and 24 months after radiation therapy if the tumor is under control. If CT or MRI shows any suspicious recurrence or metastasis, 68Ga-NY104 PET/CT can be performed at the decision of the urology oncologist or radiation oncologist. The scan begins 1 hour after intravenous injection of 68Ga-NY104.

DRUG18F-FDG PET/CT

18F-FDG PET/CT will be performed at baseline and 6 months after radiation therapy. The scan begins 1 hour after intravenous injection of 18F-FDG.

RADIATIONRadiation Therapy

Radiation therapy will be delivered to cover as much metastasis as possible if not all. For new lesions after radiation plus systemic therapy, if the new lesions are considered suitable for RT, RT can be delivered again without changing systemic therapy.

DRUGSystemic therapy

Systemic therapy will be delivered to patients to control the tumor. Possible regimen includes targeted therapy alone, immunotherapy alone, and targeted therapy combined with immunotherapy. The treatment regimen will be decided according to the urology oncologist.


Locations(1)

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT06613269


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