Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

  • STATUS
    Recruiting
  • End date
    Jan 1, 2026
  • participants needed
    39
  • sponsor
    Alpha Tau Medical LTD.
Updated on 25 March 2022
platelet count
cancer
measurable disease
warfarin
cancer treatment

Summary

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

Description

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of re-treatment with 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 either recurrent or persistent disease following DaRT treatment. .

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).

Details
Condition Skin Cancer, Mucosal Neoplasm of Oral Cavity, Soft Tissue Neoplasm
Treatment Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Clinical Study IdentifierNCT04540588
SponsorAlpha Tau Medical LTD.
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects with histopathological confirmation of either recurrent or persistent disease following DaRT treatment
Subjects with a tumor size ≤ 5 centimeters in the longest diameter
Target lesion technically amenable for full coverage with the Alpha DaRT seeds
Brachytherapy indication validated by a multidisciplinary team
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
AST and ALT ≤ 2.5 X ULN
WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
International normalized ratio of prothrombin time ≤1.4 for patients not on Warfarin
Creatinine ≤2.3 mg/dL
Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation 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

Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
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
Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
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
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)
Subjects not willing to sign an informed consent
Women who are pregnant or breastfeeding
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