Alpha Radiation Emitters Device for the Treatment of Squa... | NCT03353077

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

NCT03353077

Sponsor

Alpha Tau Medical LTD.

Status

Completed

Last Update Posted

Mar 10, 2021Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Skin Squamous Cell Carcinoma

Interventions

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 21, 2017Actual

Primary Completion Date

Jul 14, 2019Actual

Completion Date

Jul 14, 2019Actual

First Submitted Date

Nov 15, 2017

First Submission Date that Met QC Criteria

Nov 22, 2017

First Posted Date

Nov 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2021

Last Update Posted Date

Mar 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alpha DaRT	Experimental	Alpha DaRT Seeds, Diffusing alpha-emitters Radiation Therapy.	Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Percent of NecroticTissue	Percent of necrotic tissue in the tumor 30-45 days after DaRT insertion	30-45 days post seed insertion

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided