Back to resultsAlpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)
Primary Purpose
Skin Cancer, Mucosal Neoplasm of Oral Cavity, Soft Tissue Neoplasm
Status
Active
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
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, Brachytherapy
Eligibility Criteria
Inclusion Criteria:
- Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.
- Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
- Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.
- Subjects' ECOG Performance Status Scale is < 2.
- Subjects' life expectancy is more than 6 months.
- Platelet count ≥100,000/mm3.
- International normalized ratio of prothrombin time ≤1.8.
- Creatinine ≤1.9 mg/dL.
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
- Subjects are willing to sign an informed consent form.
Exclusion Criteria:
- Subject has a tumor of Keratoacanthoma histology.
- Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
- Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
- High probability of protocol non-compliance (in opinion of investigator)
- Women who are pregnant or breastfeeding.
Sites / Locations
- Davidof Cancer Institution at the Rabin Medical Center Israel
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
Tumor response to DaRT
Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Adverse Events
The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.
Secondary Outcome Measures
Reduction in tumor volume
based on imaging
DaRT seeds placement
Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion
Change in quality of life
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score
Change in quality of life
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score
Adverse Events
All Adverse Events (AE) related and unrelated to the study treatment
Progression Free Survival
Time elapsed from response to disease progression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03737734
Brief Title
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)
Official Title
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 31, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (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 size 70 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
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, Brachytherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (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)
Radiation: 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
Tumor response to DaRT
Description
Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Time Frame
9-11 weeks post DaRT insertion
Title
Adverse Events
Description
The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.
Time Frame
Up to 24 Months
Secondary Outcome Measure Information:
Title
Reduction in tumor volume
Description
based on imaging
Time Frame
9-11 weeks post DaRT insertion
Title
DaRT seeds placement
Description
Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion
Time Frame
Day of insertion procedure
Title
Change in quality of life
Description
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score
Time Frame
Day 15, Day 30, Day 70, Day 180 post DaRT insertion
Title
Change in quality of life
Description
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score
Time Frame
Day 30, Day 70, Day 180 post DaRT insertion
Title
Adverse Events
Description
All Adverse Events (AE) related and unrelated to the study treatment
Time Frame
Up to 24 Months
Title
Progression Free Survival
Description
Time elapsed from response to disease progression
Time Frame
24 months post DaRT insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.
Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.
Subjects' ECOG Performance Status Scale is < 2.
Subjects' life expectancy is more than 6 months.
Platelet count ≥100,000/mm3.
International normalized ratio of prothrombin time ≤1.8.
Creatinine ≤1.9 mg/dL.
Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
Subjects are willing to sign an informed consent form.
Exclusion Criteria:
Subject has a tumor of Keratoacanthoma histology.
Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
High probability of protocol non-compliance (in opinion of investigator)
Women who are pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noga Kurman, MD
Organizational Affiliation
Davidof Cancer Institution at Rabin Medical Center Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Davidof Cancer Institution at the Rabin Medical Center Israel
City
Petah tikva
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 Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)
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