NCT03889899

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Oct 2020Sep 2026

First Submitted

Initial submission to the registry

March 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 21, 2020

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

5.6 years

First QC Date

March 21, 2019

Last Update Submit

December 1, 2025

Conditions

Skin CancerMucosal Neoplasm of Oral CavitySoft Tissue Neoplasm

Keywords

Squamous Cell CarcinomaSCCSkin CancerSkin metastasisHNSCCCarcinoma, SquamousCMNBasal cell carcinomaSuperficial sarcomaKaposi sarcomaAlpha radiationCutaneous lesionTongue cancerLip cancer

Outcome Measures

Primary Outcomes (2)

  • Tumor response to DaRT

    Assessment of the rate of malignant cutaneous, mucosal or superficial soft tissue tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

    9-11 weeks after DaRT seed insertion.

  • Adverse Events

    The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment

    Time Frame: 9-11 weeks post DaRT insertion.

Secondary Outcomes (4)

  • Assessment of the reduction in tumor volume

    9-11 weeks follow-up visit.

  • DaRT seeds placement.

    Day of insertion procedure.

  • Change in quality of life

    Screening, DaRT removal and day 70 visits.

  • Change in quality of life

    Screening, DaRT removal and day 70 visits.

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.

DaRT Seeds

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • 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.
  • 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).
  • Subjects not willing to sign an informed consent.
  • Women who are pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAMBAM Health Care Campus

Haifa, 3109601, Israel

RECRUITING

MeSH Terms

Conditions

Skin NeoplasmsSoft Tissue NeoplasmsCarcinoma, Squamous CellSquamous Cell Carcinoma of Head and NeckCarcinoma, Basal CellSarcoma, KaposiTongue NeoplasmsLip Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous CellHead and Neck NeoplasmsNeoplasms, Basal CellHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms, Vascular TissueMouth NeoplasmsMouth DiseasesStomatognathic DiseasesTongue DiseasesLip Diseases

Study Officials

  • Tomer Charas, MD

    Radiotherapy unit at Rambam Health Care Campus, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liron Dimnik

CONTACT

+972-2-373-7000LironD@alphatau.com

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

March 21, 2019

First Posted

March 26, 2019

Study Start

October 21, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)