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

NCT03737734 | Active Not Recruiting

• 1 other identifier: CTP-CMN-02
• Study Type: interventional
• Target: 30
• 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

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

  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.

  Up to 24 Months

Secondary Outcomes (6)

• Reduction in tumor volume

  9-11 weeks post DaRT insertion

• DaRT seeds placement

  Day of insertion procedure

• Change in quality of life

  Day 15, Day 30, Day 70, Day 180 post DaRT insertion

• Change in quality of life

  Day 30, Day 70, Day 180 post DaRT insertion

• Adverse Events

  Up to 24 Months

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 primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.
• Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
• 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.
• Subjects' ECOG Performance Status Scale is \< 2.
• Subjects' life expectancy is more than 6 months.
• Platelet count ≥100,000/mm3.
• 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.
• Subjects are willing to sign an informed consent form.

You may not qualify if:

• Subject has a tumor of Keratoacanthoma histology.
• Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
• Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
• 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)
• Women who are pregnant or breastfeeding.

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (1)

Davidof Cancer Institution at the Rabin Medical Center Israel

Petah Tikva, 49100, 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

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

Study Officials

• Noga Kurman, MD

  Davidof Cancer Institution at Rabin Medical Center Israel

  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: November 8, 2018
• First Posted: November 9, 2018
• Study Start: December 31, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)