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

NCT03353077 | Completed

• 1 other identifier: CTP-SCC-000
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Squamous Cell Carcinoma

Keywords

Skin SCC; Skin Carcinoma, Squamous

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  The incidence, severity and frequency of all Adverse Events

  30-45 days post seed insertion

• Reduction in Tumor size

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

  30-45 days post seed insertion

Secondary Outcomes (1)

• Percent of NecroticTissue

  30-45 days post seed insertion

Study Arms (1)

Alpha DaRT

EXPERIMENTAL

Alpha DaRT Seeds, Diffusing alpha-emitters Radiation Therapy.

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

Interventions

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) DEVICE

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.

Also known as: DaRT

Alpha DaRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (1)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

Meldola, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 27, 2017
• Study Start: November 21, 2017
• Primary Completion: July 14, 2019
• Study Completion: July 14, 2019
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)