NCT03886181

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

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
2.3 years until next milestone

Study Start

First participant enrolled

July 8, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2024

Completed
Last Updated

December 8, 2025

Status Verified

November 1, 2025

Enrollment Period

3.3 years

First QC Date

March 21, 2019

Last Update Submit

December 1, 2025

Conditions

Skin CancerSoft Tissue NeoplasmMucosal Neoplasm of Oral Cavity

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Evaluate the safety of the DaRT treatment

    The study primary objective is to evaluate the safety of the DaRT treatment in terms of incidence of device related Serious Adverse Events (SAE).

    5-7 weeks after DaRT seed insertion.

Secondary Outcomes (1)

  • Evaluation the effectiveness of the treatment.

    Tumor volume will be measured during screening, 5 and 30-45 days post DaRT after treatment using CT.

Other Outcomes (1)

  • Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic

    15-30 days after removal of DaRT seeds.

Study Arms (1)

DaRT Seeds

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

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

Interventions

Device: 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 cutaneous and/or mucosal and/or superficial soft tissue malignant neoplasia.
  • Subjects with a tumor size ≤ 5 centimeters in the longest diameter.
  • Subjects' age is over 18 years old.
  • Subjects' ECOG Performance Status Scale is \< 2.
  • Subjects' life expectancy is more than 6 months.
  • Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
  • Subjects are able and willing to sign an informed consent form.

You may not qualify if:

  • Subject has a tumor with a maximal diameter \> 5 centimeters.
  • Subjects' ECOG Performance Status Scale is \> 3.
  • Subject has a tumor of Keratoacanthoma histology.
  • Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
  • Patients under systemic immunosuppressive and/or corticosteroid treatment. Patients taking corticosteroid inhalers are eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Dermatologico S. Gallicano, IFO - Istituti Fisioterapici Ospitalieri - Dermatologia Oncologica e Prevenzione

Rome, Lazio, Italy

Location

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

  • Laura Eibenschuz, MD

    IFO S. Gallicano

    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

March 21, 2019

First Posted

March 22, 2019

Study Start

July 8, 2021

Primary Completion

October 13, 2024

Study Completion

October 13, 2024

Last Updated

December 8, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)