Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

A Safety and Efficacy Study of Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

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

Study Overview

• Status: Completed
• Conditions: Skin Cancer; Mucosal Neoplasm of Oral Cavity; Soft Tissue Neoplasm
• Intervention / Treatment: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Sharett institute, Hadassah University Hospital - Ein-Kerem

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DaRT Seeds; Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds	Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT); 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	Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)	9-11 weeks post DaRT insertion
Adverse events	Frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.	From conscent up to 9-11 weeks post DaRT insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tumor volume	Based on imaging	9-11 weeks post DaRT insertion
Local control rate	Will be assessed as the number of complete responses, partial responses and stable disease divided by the total numbers of tumors treated.	9-11 weeks post DaRT insertion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Incidence of all Adverse Events (AE) related and unrelated to the study treatment.	From conscent up to 9-11 weeks post DaRT insertion

Collaborators and Investigators

• Sponsor: Alpha Tau Medical LTD.
• Investigators: Principal Investigator: Aron Popovtzer, M.D, Sharett institute, Hadassah Medical Center - Ein-Kerem

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Estimated): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Skin Cancer; Brachytherapy; HNSCC; Squamous Cell Carcinoma; SCC; Alpha radiation; Basal cell carcinoma; Skin metastasis; Carcinoma, Squamous; CMN; Superficial sarcoma; Kaposi sarcoma; Cutaneous lesion; Tongue cancer; Lip cancer; Recurrent disease; Persistent lesion
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Infections; Virus Diseases; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; DNA Virus Infections; Skin Diseases; Carcinoma; Neoplasms, Squamous Cell; Sarcoma; Neoplasms, Connective and Soft Tissue; Herpesviridae Infections; Neoplasms, Vascular Tissue; Lip Diseases; Neoplasms, Basal Cell; Tongue Diseases; Mouth Neoplasms; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Squamous Cell Carcinoma of Head and Neck; Recurrence; Carcinoma, Squamous Cell; Sarcoma, Kaposi; Lip Neoplasms; Skin Neoplasms; Carcinoma, Basal Cell; Soft Tissue Neoplasms; Tongue Neoplasms
• Other Study ID Numbers: CTP-CMN-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No