Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma

Not Applicable

Completed

• Conditions: Squamous Cell Carcinoma
• Interventions: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

• Registration Number: NCT03015883
• Lead Sponsor: Alpha Tau Medical LTD.

Brief Summary

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

Detailed Description

This will be a prospective, first in man, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Lesions with histopathological diagnosis of squamous cell carcinoma will be studied.

Reduction in tumor size 30 days after DaRT insertion will be assessed.

Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Study Timeline

• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-08
• Study First Posted: 2017-01-10
• Study Start: 2017-02-22
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-25
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diffusing Alpha Radiation Emitters Therapy (DaRT)	Diffusing Alpha Radiation Emitters Therapy (DaRT)	Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices

Primary Outcome Measures

Name	Time	Method
Reduction in Tumor size	30-45 days post seed insertion	The reduction in tumor size 30-45 days after DaRT insertion
Adverse Events	30-45 days post seed insertion	The incidence, severity and frequency of all Adverse Events

Secondary Outcome Measures

Name	Time	Method
Percent of NecroticTissue	30-45 days post seed insertion	Percent of necrotic tissue in the tumor 30 days after DaRT insertion

Trial Locations

Locations (1)

Davidof Cancer Institution at the Rabin Medical Center Israel; 🇮🇱 Petah Tiqva, Israel