Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05632913

Alpha Radiation Emitters Device for the Treatment of Recurrent Lung Cancer

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

10

Participants Needed

1

Research Sites

187 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 treatment of recurrent Lung Cancer .

CONDITIONS

Official Title

Alpha Radiation Emitters Device for the Treatment of Recurrent Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically and/or cytologically proven recurrent mediastinal tumors
  • Target lesion amenable for at least 50% coverage by Alpha DaRT seeds
  • Up to two treatable lesions
  • Interstitial radiation indication approved by multidisciplinary team
  • Measurable lesion per RECIST v1.1 criteria
  • Lesion size 64 3 cm in longest diameter
  • Age 18 years or older
  • ECOG Performance Status Scale 64 3
  • Life expectancy more than 6 months
  • White blood cell count 65 3500/�b5l, granulocyte 65 1500/�b5l
  • Platelet count 60,000/�b5l
  • Creatinine clearance 60 cc/min or 65 40 cc/min with stable creatinine levels over past 3 weeks
  • AST and ALT 64 2.5 times upper limit of normal
  • INR less than 1.4 for patients not on Warfarin
  • Willing and able to sign informed consent
  • Women of childbearing potential must have negative pregnancy test before Ra-224 implantation and use contraception for 3 months after treatment
Not Eligible

You will not qualify if you...

  • Receiving chemotherapy or immunotherapy currently
  • Brain metastases or connective tissue diseases such as scleroderma or lupus
  • Known allergy to any treatment components
  • Undergoing systemic immunosuppressive therapy except short corticosteroids use
  • Clinically significant cardiovascular disease including severe heart failure, uncontrolled coronary disease, cardiomyopathy, arrhythmia, uncontrolled hypertension, or recent myocardial infarction within 12 months
  • Uncontrolled infections, psychiatric or substance abuse disorders interfering with study participation
  • Additional progressing malignancy needing active treatment, except certain skin or cervical cancers
  • Requires treatments not specified in this protocol that could interfere with study outcomes
  • Unwilling or unable to use adequate contraception before, during, and 3 months after study
  • Participation in another interventional study within past 30 days that conflicts with this study
  • High risk of not following the study protocol
  • Breastfeeding or women of childbearing potential unwilling to use contraception for 3 months post-treatment

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

Hadassah University Hospital

Jerusalem, Israel, 9777605

Actively Recruiting

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Research Team

L

Liron Dimnik

CONTACT

A

Aviya Hoida

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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