Clinical trial NCT03353077: Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma (DaRT)
Official title: A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Squamous Cell Carcinoma
Keywords: Skin SCC
Skin Carcinoma, Squamous
Lead sponsor: Alpha Tau Medical LTD.
Sponsor class: INDUSTRY
First posted: 2017-11-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: A unique approach for Skin Squamous Cell Carcinoma (SCC) treatment employing intratumoral diffusing alpha radiation emitter device

Detailed description: This will be a prospective study, assessing the safety and effectiveness of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of Skin Squamous Cell Carcinoma (SCC) tumors.

Treatment will be delivered through radioactive sources (Alpha DaRT seeds) inserted into the tumors in the skin. 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 30-45 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Eligibility criteria: Inclusion Criteria:

* Subjects with histopathological confirmation of skin squamous cell carcinoma before surgical removal of the tumor.
* Subjects with a tumor size ≤ 5 centimeters in the longest diameter (lesions without nodal spread).
* Subjects' age is over 18 years old.
* Subjects' ECOG Performance Status Scale is ≤ 2.
* Subjects' life expectancy is more than 6 months.
* Female subjects of childbearing age will have evidence of negative pregnancy test.
* Subjects are willing to sign an informed consent form.

Exclusion Criteria:

* Subject has a tumor with a maximal diameter \> 5 centimeters.
* Subject has an ulcerative lesion.
* Subject has a tumor of Keratoacanthoma histology.
* Subjects' ECOG Performance Status Scale is ≥ 3.
* Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
* Patients under immunosuppressive and/or corticosteroid treatment.
* Volunteers that participated in other studies in the past 30 days that might affect the evaluation of response or toxicity of DaRT.
* Pregnant women.
* Subjects not willing to sign an informed consent form.

Primary outcomes:
measure: Adverse Events
timeFrame: 30-45 days post seed insertion
measure: Reduction in Tumor size
timeFrame: 30-45 days post seed insertion
Secondary outcomes:
measure: Percent of NecroticTissue
timeFrame: 30-45 days post seed insertion
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Study officials:
References: