Back to resultsAlpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)
Primary Purpose
Skin Cancer, Mucosal Neoplasm of Oral Cavity, Soft Tissue Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Sponsored by
About this trial
This is an interventional treatment trial for Skin Cancer focused on measuring 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
Eligibility 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.
Sites / Locations
- IRCCS Istituto Dermatologico S. Gallicano, IFO - Istituti Fisioterapici Ospitalieri - Dermatologia Oncologica e PrevenzioneRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DaRT Seeds
Arm Description
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Outcomes
Primary Outcome Measures
Evaluate the safety of the DaRT treatment
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
Evaluation the effectiveness of the treatment.
Evaluation on the effectiveness of the DaRT treatment, in terms of tumor volume reduction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03886181
Brief Title
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)
Official Title
A Safety and Preliminary Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
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 for superficial cutaneous, mucosal or soft tissue neoplasia
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer, Mucosal Neoplasm of Oral Cavity, Soft Tissue Neoplasm
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DaRT Seeds
Arm Type
Experimental
Arm Description
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Intervention Type
Device
Intervention Name(s)
Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (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
Evaluate the safety of the DaRT treatment
Description
The study primary objective is to evaluate the safety of the DaRT treatment in terms of incidence of device related Serious Adverse Events (SAE).
Time Frame
5-7 weeks after DaRT seed insertion.
Secondary Outcome Measure Information:
Title
Evaluation the effectiveness of the treatment.
Description
Evaluation on the effectiveness of the DaRT treatment, in terms of tumor volume reduction.
Time Frame
Tumor volume will be measured during screening, 5 and 30-45 days post DaRT after treatment using CT.
Other Pre-specified Outcome Measures:
Title
Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic
Description
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.
Time Frame
15-30 days after removal of DaRT seeds.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liron Dimnik
Phone
+972-2-373-7000
Email
LironD@alphatau.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Eibenschuz, MD
Organizational Affiliation
IFO S. Gallicano
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Dermatologico S. Gallicano, IFO - Istituti Fisioterapici Ospitalieri - Dermatologia Oncologica e Prevenzione
City
Rome
State/Province
Lazio
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Eibenschuz, MD
First Name & Middle Initial & Last Name & Degree
Laura Eibenschuz, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)
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