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

Not Applicable

Recruiting

• Conditions: Skin Cancer; Mucosal Neoplasm of Oral Cavity; Soft Tissue Neoplasm

• Registration Number: NCT04534127
• Lead Sponsor: Alpha Tau Medical LTD.

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).

Study Timeline

• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-30
• Study First Posted: 2020-09-01
• Study Start: 2020-12-22
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tumor response to DaRT	9-11 weeks post DaRT insertion	Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Adverse Events	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	24 months post DaRT insertion	Time elapsed from response to disease progression
Change in tumor volume	9-11 weeks post DaRT insertion	Based on imaging
DaRT seeds placement	1 Day of procedure	Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion
Change in quality of life	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

Trial Locations

Locations (1)

Sharett institute, Hadassah Medical Center - Ein-Kerem; 🇮🇱 Jerusalem, Israel