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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015883
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

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

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma (First in Man)
Actual Study Start Date : February 22, 2017
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 25, 2019

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 Name: DaRT




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 30-45 days post seed insertion ]
    The incidence, severity and frequency of all Adverse Events

  2. Reduction in Tumor size [ Time Frame: 30-45 days post seed insertion ]
    The reduction in tumor size 30-45 days after DaRT insertion


Secondary Outcome Measures :
  1. Percent of NecroticTissue [ Time Frame: 30-45 days post seed insertion ]
    Percent of necrotic tissue in the tumor 30 days after DaRT insertion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015883


Locations
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Israel
Davidof Cancer Institution at the Rabin Medical Center Israel
Petah Tiqva, Israel, 49100
Sponsors and Collaborators
Alpha Tau Medical LTD.
Investigators
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Principal Investigator: Aharon Popovtzer, MD Davidof Cancer Institution at the Rabin Medical Center Israel
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Responsible Party: Alpha Tau Medical LTD.
ClinicalTrials.gov Identifier: NCT03015883    
Other Study ID Numbers: CTP-SCC-00
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alpha Tau Medical LTD.:
Squamous Cell Carcinoma
Alpha emitting radiation
Skin Cancer
Carcinoma, Squamous
HNSCC
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell