Clinical trial NCT03886181: Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)
Official title: A Safety and Preliminary Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Cancer
Mucosal Neoplasm of Oral Cavity
Soft Tissue Neoplasm
Keywords: Squamous Cell Carcinoma
SCC
Skin Cancer
Skin metastasis
HNSCC
Carcinoma, Squamous
CMN
Basal cell carcinoma
Superficial sarcoma
Kaposi sarcoma
Alpha radiation
Cutaneous lesion
Tongue cancer
Lip cancer
Lead sponsor: Alpha Tau Medical LTD.
Sponsor class: INDUSTRY
First posted: 2019-03-22
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

Detailed description: This will be a prospective, open label, single arm, 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.

Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor volume and evaluation the percent of necrotic tissue in the tumor 30-45 days after DaRT seeds insertion (15-30 days after seed removal) will be assessed. Safety will be assessed by the cumulative incidence, worst severity and frequency of adverse events (AEs) observed including the follow-up period.

Eligibility criteria: Inclusion Criteria:

* Subjects with histopathological confirmation of cutaneous and/or mucosal and/or superficial soft tissue malignant neoplasia.
* Subjects with a tumor size ≤ 5 centimeters in the longest diameter.
* Subjects' age is over 18 years old.
* Subjects' ECOG Performance Status Scale is \< 2.
* Subjects' life expectancy is more than 6 months.
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
* Subjects are able and willing to sign an informed consent form.

Exclusion Criteria:

* Subject has a tumor with a maximal diameter \> 5 centimeters.
* Subjects' ECOG Performance Status Scale is \> 3.
* Subject has a tumor of Keratoacanthoma histology.
* Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
* Patients under systemic immunosuppressive and/or corticosteroid treatment. Patients taking corticosteroid inhalers are eligible.

Primary outcomes:
measure: Evaluate the safety of the DaRT treatment
timeFrame: 5-7 weeks after DaRT seed insertion.
Secondary outcomes:
measure: Evaluation the effectiveness of the treatment.
timeFrame: Tumor volume will be measured during screening, 5 and 30-45 days post DaRT after treatment using CT.
Other outcomes:
measure: Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic
timeFrame: 15-30 days after removal of DaRT seeds.
Locations:
city: Rome
country: Italy
facility: IRCCS Istituto Dermatologico S. Gallicano, IFO - Istituti Fisioterapici Ospitalieri - Dermatologia Oncologica e Prevenzione
state: Lazio
Study officials:
affiliation: IFO S. Gallicano
name: Laura Eibenschuz, MD
role: PRINCIPAL_INVESTIGATOR
References: