Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

NCT04540588 | Completed

• 1 other identifier: CTP-CMN-05
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Cancer; Mucosal Neoplasm of Oral Cavity; Soft Tissue Neoplasm

Keywords

Squamous Cell Carcinoma; SCC; Skin Cancer; Skin metastasis; HNSCC; Carcinoma, Squamous; CMN; Basal cell carcinoma; Superficial sarcoma; Kaposi sarcoma; Alpha radiation; Cutaneous lesion; Tongue cancer; Lip cancer; Brachytherapy; Recurrent disease; Persistent lesion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in tumor volume

  9-11 weeks post DaRT insertion

• Local control rate

  9-11 weeks post DaRT insertion

Other Outcomes (1)

• Adverse Events

  From conscent up to 9-11 weeks post DaRT insertion

Study Arms (1)

DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Interventions

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) DEVICE

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.

Also known as: DaRT

DaRT Seeds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (1)

Sharett institute, Hadassah University Hospital - Ein-Kerem

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Skin Neoplasms; Soft Tissue Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Basal Cell; Sarcoma, Kaposi; Tongue Neoplasms; Lip Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms, Basal Cell; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Vascular Tissue; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases; Lip Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aron Popovtzer, M.D

  Sharett institute, Hadassah Medical Center - Ein-Kerem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: September 7, 2020
• Study Start: December 22, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

IL (1)