This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886181
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : July 25, 2023
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

Condition or disease Intervention/treatment Phase
Skin Cancer Mucosal Neoplasm of Oral Cavity Soft Tissue Neoplasm Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) Not Applicable

Detailed Description:

This will be a prospective, open label, single arm, 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.

Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor volume and evaluation the percent of necrotic tissue in the tumor 30-45 days after DaRT seeds insertion (15-30 days after seed removal) will be assessed. Safety will be assessed by the cumulative incidence, worst severity and frequency of adverse events (AEs) observed including the follow-up period.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Preliminary Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia
Actual Study Start Date : July 8, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
 Device: Device: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Evaluate the safety of the DaRT treatment [ Time Frame: 5-7 weeks after DaRT seed insertion. ]
    The study primary objective is to evaluate the safety of the DaRT treatment in terms of incidence of device related Serious Adverse Events (SAE).


Secondary Outcome Measures :
  1. Evaluation the effectiveness of the treatment. [ Time Frame: Tumor volume will be measured during screening, 5 and 30-45 days post DaRT after treatment using CT. ]
    Evaluation on the effectiveness of the DaRT treatment, in terms of tumor volume reduction.


Other Outcome Measures:
  1. Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic [ Time Frame: 15-30 days after removal of DaRT seeds. ]
    Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic tissue present in the remaining tumor tissue surgically removed 15-30 days after removal of DaRT seeds.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Subjects with histopathological confirmation of cutaneous and/or mucosal and/or superficial soft tissue malignant neoplasia.
  • Subjects with a tumor size ≤ 5 centimeters in the longest diameter.
  • Subjects' age is over 18 years old.
  • Subjects' ECOG Performance Status Scale is < 2.
  • Subjects' life expectancy is more than 6 months.
  • Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
  • Subjects are able and willing to sign an informed consent form.

Exclusion Criteria:

  • Subject has a tumor with a maximal diameter > 5 centimeters.
  • Subjects' ECOG Performance Status Scale is > 3.
  • Subject has a tumor of Keratoacanthoma histology.
  • Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
  • Patients under systemic immunosuppressive and/or corticosteroid treatment. Patients taking corticosteroid inhalers are eligible.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03886181


Contacts
Layout table for location contacts
Contact: Liron Dimnik +972-2-373-7000 LironD@alphatau.com

Locations
Layout table for location information
Italy
IRCCS Istituto Dermatologico S. Gallicano, IFO - Istituti Fisioterapici Ospitalieri - Dermatologia Oncologica e Prevenzione Recruiting
Rome, Lazio, Italy
Contact: Laura Eibenschuz, MD         
Principal Investigator: Laura Eibenschuz, MD         
Sponsors and Collaborators
Alpha Tau Medical LTD.
Investigators
Layout table for investigator information
Principal Investigator: Laura Eibenschuz, MD IFO S. Gallicano
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Alpha Tau Medical LTD.
ClinicalTrials.gov Identifier: NCT03886181    
Other Study ID Numbers: CTP-CMN-01
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: July 25, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
SCC
Skin Cancer
Skin metastasis
HNSCC
Carcinoma, Squamous
CMN
 Basal cell carcinoma
Superficial sarcoma
Kaposi sarcoma
Alpha radiation
Cutaneous lesion
Tongue cancer
Lip cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Skin Neoplasms
Soft Tissue Neoplasms
Mouth Neoplasms
Neoplasms by Site
 Skin Diseases
Head and Neck Neoplasms
Mouth Diseases
Stomatognathic Diseases