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

January 12, 2021 updated by: Alpha Tau Medical LTD.

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma (First in Man)

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah Tiqva, Israel, 49100
        • Davidof Cancer Institution at the Rabin Medical Center Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices
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.
Other Names:
  • DaRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 30-45 days post seed insertion
The incidence, severity and frequency of all Adverse Events
30-45 days post seed insertion
Reduction in Tumor size
Time Frame: 30-45 days post seed insertion
The reduction in tumor size 30-45 days after DaRT insertion
30-45 days post seed insertion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alpha Tau Medical LTD.

Investigators

  • Principal Investigator: Noga Kurman, MD, Davidof Cancer Institution at the Rabin Medical Center Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 22, 2017

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 25, 2019

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 8, 2017

First Posted (ESTIMATE)

January 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-SCC-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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