Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma

Squamous Cell Carcinoma Clinical Trial

— DaRT  

Official title:

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma (First in Man)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015883
• Other study ID #: CTP-SCC-00
• Status: Completed
• Phase: N/A
• Start date: February 22, 2017
• Est. completion date: June 25, 2019

Study information

• Verified date: January 2021
• Source: Alpha Tau Medical LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 25, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Israel	Davidof Cancer Institution at the Rabin Medical Center Israel	Petah Tiqva

Sponsors (1)

Lead Sponsor	Collaborator
Alpha Tau Medical LTD.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	The incidence, severity and frequency of all Adverse Events	30-45 days post seed insertion
Primary	Reduction in Tumor size	The reduction in tumor size 30-45 days after DaRT insertion	30-45 days post seed insertion
Secondary	Percent of NecroticTissue	Percent of necrotic tissue in the tumor 30 days after DaRT insertion	30-45 days post seed insertion