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

Primary Purpose

Squamous Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
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 Squamous Cell Carcinoma focused on measuring Squamous Cell Carcinoma, Alpha emitting radiation, Skin Cancer, Carcinoma, Squamous, HNSCC

Eligibility Criteria

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

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.

Sites / Locations

  • Davidof Cancer Institution at the Rabin Medical Center Israel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diffusing Alpha Radiation Emitters Therapy (DaRT)

Arm Description

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices

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 days after DaRT insertion

Full Information

First Posted
January 5, 2017
Last Updated
January 12, 2021
Sponsor
Alpha Tau Medical LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT03015883
Brief Title
Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma
Acronym
DaRT
Official Title
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma (First in Man)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 25, 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 cancer treatment employing intratumoral diffusing alpha radiation emitter device.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma
Keywords
Squamous Cell Carcinoma, Alpha emitting radiation, Skin Cancer, Carcinoma, Squamous, HNSCC

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Diffusing Alpha Radiation Emitters Therapy (DaRT)
Arm Type
Experimental
Arm Description
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices
Intervention Type
Radiation
Intervention Name(s)
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 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: Histopathological confirmation of squamous cell carcinoma. Tumor size ≤ 5 centimeters in the longest diameter. Age over 18. Women of childbearing potential will have evidence of negative pregnancy test. Life expectancy of more than 6 months. Performance status 2 (ECOG scale) or less. Signed informed consent form. Exclusion Criteria: Tumor maximal diameter > 5 centimeters. Tumor of Keratoacanthoma histology. Performance status ≥ 3 (ECOG scale). Patients with moribund diseases, autoimmune diseases or vasculitis. Patients under immunosuppressive and/or corticosteroid treatment. Volunteers that participated in other studies in the past 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noga Kurman, MD
Organizational Affiliation
Davidof Cancer Institution at the Rabin Medical Center Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Davidof Cancer Institution at the Rabin Medical Center Israel
City
Petah Tiqva
ZIP/Postal Code
49100
Country
Israel

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

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