Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-25 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 12:22 AM
NCT ID: NCT06964958
Brief Summary: This study aims to evaluate the efficacy and safety of 177Lu-PSMA-617 as a systemic therapy in patients with PSMA-positive advanced clear cell renal cell carcinoma (ccRCC). The name of the study drug involved in this research study is: -177Lu-PSMA-617 (a type of radioligand therapy)
Detailed Description: The goal of this single-center, phase 2 research study is to evaluate the efficacy and safety of 177Lu-PSMA-617 as a systemic therapy in participants with PSMA-positive advanced clear cell renal cell carcinoma (ccRCC). 177Lu-PSMA-617 aims to deliver targeted radiation to cancer cells, leading to cell death. The U.S. Food and Drug Administration (FDA) has not approved 177Lu-PSMA-617 as a treatment option for advanced ccRCC, but the study drug is approved for advanced prostate cancer. The research study procedures include screening for eligibility, in-clinic visits, blood tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, and Prostate-Specific Membrane Antigen Positron Emission Tomography (PSMA PET) scans. Participants will receive study treatment for up to 6 cycles, or approximately 252 days, and will be followed every 6 months for up to 5 years after discontinuing treatment. It is expected that about 24 people will take part in this research study. Novartis Pharmaceuticals Corporation is supporting this research study by supplying the study drug (177Lu-PSMA-617) and providing funding for the study.
Study: NCT06964958
Study Brief:
Protocol Section: NCT06964958