A Study of DaRT Radiation Therapy for People With Squamous Cell Carcinoma of the Skin

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Full Title

A Prospective International Multicenter, Pivotal, Single Arm, Open Label Clinical Study to Assess the Efficacy and Safety of Intratumoral Alpha DaRT224 for the Treatment of Patients with Recurrent Cutaneous Squamous Cell Carcinoma

Purpose

In this study, researchers want to see if a new device is useful for treating squamous cell skin cancer. This cancer is also called cutaneous squamous cell carcinoma. People in this study have squamous cell skin cancer that came back after treatment. The device is called “diffusing alpha-emitter radiation therapy” (DaRT). It is placed in the tumor, under the skin, and gives off radiation to kill cancer cells.

DaRT gives off radiation in the form of alpha particles. These particles may be better at killing skin cancer cells than the usual radiation therapy. Alpha particles may also focus on destroying cancer cells while sparing more healthy cells.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have squamous cell skin cancer that came back after treatment and has not spread to other organs.
  • Have a skin tumor that is no larger than 7 cm at its longest point.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please contact Dr. Christopher Barker’s office at 212-639-8168.

Protocol

23-068

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05323253