NCT03015883

Brief Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 5, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 22, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2019

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

January 5, 2017

Last Update Submit

January 12, 2021

Conditions

Squamous Cell Carcinoma

Keywords

Squamous Cell CarcinomaAlpha emitting radiationSkin CancerCarcinoma, SquamousHNSCC

Outcome Measures

Primary Outcomes (2)

  • Adverse Events

    The incidence, severity and frequency of all Adverse Events

    30-45 days post seed insertion

  • Reduction in Tumor size

    The reduction in tumor size 30-45 days after DaRT insertion

    30-45 days post seed insertion

Secondary Outcomes (1)

  • Percent of NecroticTissue

    30-45 days post seed insertion

Study Arms (1)

Diffusing Alpha Radiation Emitters Therapy (DaRT)

EXPERIMENTAL

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Interventions

Diffusing Alpha Radiation Emitters Therapy (DaRT)RADIATION

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
Diffusing Alpha Radiation Emitters Therapy (DaRT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histopathological confirmation of squamous cell carcinoma.
  • Tumor size ≤ 5 centimeters in the longest diameter.
  • Age over 18.
  • Women of childbearing potential will have evidence of negative pregnancy test.
  • Life expectancy of more than 6 months.
  • Performance status 2 (ECOG scale) or less.
  • Signed informed consent form.

You may not qualify if:

  • Tumor maximal diameter \> 5 centimeters.
  • Tumor of Keratoacanthoma histology.
  • Performance status ≥ 3 (ECOG scale).
  • Patients with moribund diseases, autoimmune diseases or vasculitis.
  • Patients under immunosuppressive and/or corticosteroid treatment.
  • Volunteers that participated in other studies in the past 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Davidof Cancer Institution at the Rabin Medical Center Israel

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Carcinoma, Squamous CellSkin NeoplasmsSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesHead and Neck Neoplasms

Study Officials

  • Noga Kurman, MD

    Davidof Cancer Institution at the 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

January 5, 2017

First Posted

January 10, 2017

Study Start

February 22, 2017

Primary Completion

June 1, 2019

Study Completion

June 25, 2019

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)