Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma (DaRT)

Skin Squamous Cell Carcinoma Clinical Trial

Official title:

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353077
• Other study ID #: CTP-SCC-000
• Status: Completed
• Phase: N/A
• Start date: November 21, 2017
• Est. completion date: July 14, 2019

Study information

• Verified date: March 2021
• Source: Alpha Tau Medical LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A unique approach for Skin Squamous Cell Carcinoma (SCC) treatment employing intratumoral diffusing alpha radiation emitter device

Description:

This will be a prospective study, assessing the safety and effectiveness of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of Skin Squamous Cell Carcinoma (SCC) tumors. Treatment will be delivered through radioactive sources (Alpha DaRT seeds) inserted into the tumors in the skin. 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 30-45 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 14, 2019
• Est. primary completion date: July 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with histopathological confirmation of skin squamous cell carcinoma before surgical removal of the tumor.
• Subjects with a tumor size = 5 centimeters in the longest diameter (lesions without nodal spread).
• Subjects' age is over 18 years old.
• Subjects' ECOG Performance Status Scale is = 2.
• Subjects' life expectancy is more than 6 months.
• Female subjects of childbearing age will have evidence of negative pregnancy test.
• Subjects are willing to sign an informed consent form.

Exclusion Criteria:

• Subject has a tumor with a maximal diameter > 5 centimeters.
• Subject has an ulcerative lesion.
• Subject has a tumor of Keratoacanthoma histology.
• Subjects' ECOG Performance Status Scale is = 3.
• Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
• Patients under immunosuppressive and/or corticosteroid treatment.
• Volunteers that participated in other studies in the past 30 days that might affect the evaluation of response or toxicity of DaRT.
• Pregnant women.
• Subjects not willing to sign an informed consent form.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Skin Squamous Cell Carcinoma

Intervention

Device:
• Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
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.

Locations

Country	Name	City	State
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)	Meldola

Sponsors (1)

Lead Sponsor	Collaborator
Alpha Tau Medical LTD.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	The incidence, severity and frequency of all Adverse Events	30-45 days post seed insertion
Primary	Reduction in Tumor size	The reduction in tumor size 30-45 days after DaRT insertion	30-45 days post seed insertion
Secondary	Percent of NecroticTissue	Percent of necrotic tissue in the tumor 30-45 days after DaRT insertion	30-45 days post seed insertion