Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma

NCT ID: NCT03015883

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2019-06-25

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).

Conditions

Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diffusing Alpha Radiation Emitters Therapy (DaRT)

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

Group Type: EXPERIMENTAL

Diffusing Alpha Radiation Emitters Therapy (DaRT)

Intervention Type: 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.

Interventions

Diffusing Alpha Radiation Emitters Therapy (DaRT)

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.

Intervention Type: RADIATION

Other Intervention Names

DaRT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alpha Tau Medical LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noga Kurman, MD

Role: PRINCIPAL_INVESTIGATOR

Davidof Cancer Institution at the Rabin Medical Center Israel

Locations

Davidof Cancer Institution at the Rabin Medical Center Israel

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

CTP-SCC-00

Identifier Type: -

Identifier Source: org_study_id