Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia

July 23, 2023 updated by: Alpha Tau Medical LTD.

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

Study Overview

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).

Study Type

Interventional

Enrollment (Estimated)

56

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 Contact

Study Locations

      • Jerusalem, Israel, 91120
        • Recruiting
        • Sharett institute, Hadassah Medical Center - Ein-Kerem
        • Contact:
          • Aron Popovtzer, MD

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

Description

Inclusion Criteria:

  • Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. Confirmation obtained within 6 months of planned treatment.
  • Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
  • Targetable lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds
  • Brachytherapy indication validated by a multidisciplinary team
  • 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.
  • Measurable disease according to RECIST v1.1.
  • Subjects over 18 years old.
  • Subjects' ECOG Performance Status Scale is < 2.
  • Subjects' life expectancy is more than 6 months.
  • Platelet count ≥100,000/mm3.
  • WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
  • AST and ALT ≤ 2.5 X ULN
  • 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 and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.
  • Subjects are willing to sign an informed consent form.

Exclusion Criteria:

  • Subject has a tumor of Keratoacanthoma histology.
  • Known hypersensitivity to any of the components of the treatment.
  • Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
  • Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.
  • Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
  • Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT
  • 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.
  • Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
  • High probability of protocol non-compliance (in opinion of investigator).
  • Subjects not willing to sign an informed consent.
  • Women who are pregnant or breastfeeding.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
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
Tumor response to DaRT
Time Frame: 9-11 weeks post DaRT insertion
Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
9-11 weeks post DaRT insertion
Adverse Events
Time Frame: Up to 24 Months
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.
Up to 24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tumor volume
Time Frame: 9-11 weeks post DaRT insertion
Based on imaging
9-11 weeks post DaRT insertion
DaRT seeds placement
Time Frame: 1 Day of procedure
Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion
1 Day of procedure
Change in quality of life
Time Frame: Day 15, Day 30, Day 70, Day 180 post DaRT insertion
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score
Day 15, Day 30, Day 70, Day 180 post DaRT insertion
Change in quality of life
Time Frame: Day 30, Day 70, Day 180 post DaRT insertion
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score
Day 30, Day 70, Day 180 post DaRT insertion
Progression Free Survival
Time Frame: 24 months post DaRT insertion
Time elapsed from response to disease progression
24 months post DaRT insertion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to 24 Months
All Adverse Events (AE) related and unrelated to the study treatment
Up to 24 Months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Aron Popovtzer, Sharett institute, Hadassah University Hospital - Ein-Kerem

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)

December 22, 2020

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 30, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

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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