Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03889899

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

Led by Alpha Tau Medical LTD. · Updated on 2025-12-02

30

Participants Needed

1

Research Sites

305 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathological confirmation of primary or secondary malignant cutaneous lesions, oral cavity mucosal tumors, or superficial soft tissue sarcoma
  • Tumor size 7 centimeters or less in longest diameter
  • Measurable disease according to RECIST v1.1
  • Age 18 years or older
  • ECOG Performance Status less than 2
  • Life expectancy more than 6 months
  • Platelet count of at least 100,000/mm3
  • International normalized ratio of prothrombin time 1.8 or less
  • Creatinine 1.9 mg/dL or less
  • Negative pregnancy test for women of childbearing potential
  • Willingness to sign informed consent form
Not Eligible

You will not qualify if you...

  • Tumor with Keratoacanthoma histology
  • Significant comorbidities that may interfere with study endpoints (e.g., poorly controlled autoimmune diseases, vasculitis)
  • Ongoing systemic immunosuppressive therapy except brief, intermittent corticosteroids
  • Participation in another interventional study within the past 30 days that may conflict with this study
  • High probability of protocol non-compliance
  • Unwillingness to sign informed consent
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

RAMBAM Health Care Campus

Haifa, Israel, 3109601

Actively Recruiting

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Research Team

L

Liron Dimnik

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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