Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma

Alpha Tau Medical LTD.28 enrolled

Overview

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device.

This will be a prospective, first in man, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. Lesions with histopathological diagnosis of squamous cell carcinoma will be studied. Reduction in tumor size 30 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Squamous Cell Carcinoma

Interventions

Diffusing Alpha Radiation Emitters Therapy (DaRT)RADIATION

An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histopathological confirmation of squamous cell carcinoma. 2. Tumor size ≤ 5 centimeters in the longest diameter. 3. Age over 18. 4. Women of childbearing potential will have evidence of negative pregnancy test. 5. Life expectancy of more than 6 months. 6. Performance status 2 (ECOG scale) or less. 7. Signed informed consent form. Exclusion Criteria: 1. Tumor maximal diameter \> 5 centimeters. 2. Tumor of Keratoacanthoma histology. 3. Performance status ≥ 3 (ECOG scale). 4. Patients with moribund diseases, autoimmune diseases or vasculitis. 5. Patients under immunosuppressive and/or corticosteroid treatment. 6. Volunteers that participated in other studies in the past 30 days.

Locations (1)

Davidof Cancer Institution at the Rabin Medical Center Israel

Petah Tikva, Israel

Outcomes

Primary Outcomes

Adverse Events

The incidence, severity and frequency of all Adverse Events

Time frame: 30-45 days post seed insertion

Reduction in Tumor size

The reduction in tumor size 30-45 days after DaRT insertion

Time frame: 30-45 days post seed insertion

Secondary Outcomes

Percent of NecroticTissue

Percent of necrotic tissue in the tumor 30 days after DaRT insertion

Time frame: 30-45 days post seed insertion

Data from ClinicalTrials.gov

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