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

Primary Purpose

Skin Squamous Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Sponsored by
Alpha Tau Medical LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Squamous Cell Carcinoma focused on measuring Skin SCC, Skin Carcinoma, Squamous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alpha DaRT

Arm Description

Alpha DaRT Seeds, Diffusing alpha-emitters Radiation Therapy.

Outcomes

Primary Outcome Measures

Adverse Events
The incidence, severity and frequency of all Adverse Events
Reduction in Tumor size
The reduction in tumor size 30-45 days after DaRT insertion

Secondary Outcome Measures

Percent of NecroticTissue
Percent of necrotic tissue in the tumor 30-45 days after DaRT insertion

Full Information

First Posted
November 15, 2017
Last Updated
March 9, 2021
Sponsor
Alpha Tau Medical LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT03353077
Brief Title
Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma (DaRT)
Official Title
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
July 14, 2019 (Actual)
Study Completion Date
July 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alpha Tau Medical LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Squamous Cell Carcinoma
Keywords
Skin SCC, Skin Carcinoma, Squamous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alpha DaRT
Arm Type
Experimental
Arm Description
Alpha DaRT Seeds, Diffusing alpha-emitters Radiation Therapy.
Intervention Type
Device
Intervention Name(s)
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Other Intervention Name(s)
DaRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events
Description
The incidence, severity and frequency of all Adverse Events
Time Frame
30-45 days post seed insertion
Title
Reduction in Tumor size
Description
The reduction in tumor size 30-45 days after DaRT insertion
Time Frame
30-45 days post seed insertion
Secondary Outcome Measure Information:
Title
Percent of NecroticTissue
Description
Percent of necrotic tissue in the tumor 30-45 days after DaRT insertion
Time Frame
30-45 days post seed insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
City
Meldola
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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