Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Carcinoma

Skin Neoplasms

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. Objective Response Rate (ORR) will be determined based on confirmed BOR following DaRT insertion.

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed.

DaRT seeds

Liron Dimnik

Aviya Hoida

Michael Samuels, MD

Pamela Urban

Shyamal Patel, MD

Rebecca Pena

Albert Chang, MD

Jackie Hernandez

Yi Jen Chen, MD

Hesham Mahmoud

Michael E Kasper, MD

Ileana Vargas

Matthew Abramowitz, MD

Zuzel Rodrigues

Noah S Kalman, MD

Evan Wuthrick, MD

Zachary Buchwald, MD

Stacie Hitchcook

Arshin Sheybani, MD

Sheila Young

Mauricio Gamez, MD

Benjamin Rosenbluth, MD

Lydia M Ko

Gregg E.Franklin, MD

Sarah Tellez

Timothy Korytko, MD

Katelyn Tessier

Bhupesh Parashar, MD

Christipher Barker, MD

Ming Lian

Joshua Palmer, MD

Sujith Baliga

Noam Vanderwalde, MD

Catherine Morningstar

Mark D'Andrea, MD

Jo Ann Ramirez

Christopher McLaughlin, MD

Song Wood

Elie Levy, MD

Tomer Charas, MD

Aron Popovtzer, MD

Elisha Fredman, MD

Iris Gluck, MD

Shlomit Shamir Druskin

This is a multi-center clinical study enrolling up to 86 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy, as well as to assess the Duration of Response (DOR) 6 months from initial response. Secondary objectives are to assess the safety of DaRT, and to assess the progression free survival (PFS), overall survival (OS), Overall Duration of Response (O-DOR), local control and quality of life (QOL) for patients treated with DaRT.

This study is a prospective multicenter, pivotal, single arm, open label clinical study to assess the efficacy and safety of intratumoral Alpha DaRT-224 for the treatment of patients with recurrent cutaneous squamous cell carcinoma.

The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. DaRT seeds will be inserted into recurrent Squamous Cell Carcinoma (SCC) tumors and will be removed following 14-21 days.

The Objective Response Rate (ORR) will be determined based on the confirmed Best Overall Response (BOR) following DaRT insertion. Duration of Response (DOR) will be assessed for up to 6 months from initial response is documented. Safety will be assessed based on the cumulative incidence rate, severity and outcome of device related Adverse Events (AEs). Classification of AEs will be done according to CTCAE v5.

This is an International Multicenter, Pivotal, Single Arm, Open Label pivotal trial with DaRT for the treatment of Recurrent Cutaneous Squamous Cell Carcinoma

A Clinical Study to Assess the Efficacy and Safety of Alpha DaRT224 for the Treatment of Patients With Recurrent Cutaneous Squamous Cell Carcinoma

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

Objective Response Rate (ORR) of DaRT as treatment for Recurrent SCC established by the confirmed Best Overall Response (BOR), with confirmation at least 4 weeks after initial assessment

Assess the Duration of Response (DOR) of DaRT as treatment for Recurrent SCC

Determine Progression Free Survival (PFS) of SCC following DaRT treatment

Assess Overall Survival (OS) of Recurrent SCC patients treated with DaRT

Local control of SCC following DaRT treatment is measured as the time from first recorded response (Complete Response/Partial Response/Stable Disease) to local recurrence up to 12 months or last follow up

Assess patient reported health related quality of life (QOL) outcomes using the Skin Cancer Index (SCI) and Skindex-16 questionnaires

Assess the safety of the Alpha DaRT treatment, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE v5

O-DOR Defined as the time from first response (CR or PR) to the date of initial objectively documented progression or death due to any cause, whichever occurs first.

Assess user experience as determined by questionnaire

Alpha Tau Medical LTD.

Spots Global Cancer Trial Database for recurrent squamous cell carcinoma