Mucosal Neoplasm of Oral Cavity, Skin Cancer, Soft Tissue Neoplasm
Conditions
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
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.
Interventions
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.
Sponsors
Alpha Tau Medical LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety of the DaRT treatment | 5-7 weeks after DaRT seed insertion. | The study primary objective is to evaluate the safety of the DaRT treatment in terms of incidence of device related Serious Adverse Events (SAE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation the effectiveness of the treatment. | Tumor volume will be measured during screening, 5 and 30-45 days post DaRT after treatment using CT. | Evaluation on the effectiveness of the DaRT treatment, in terms of tumor volume reduction. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic | 15-30 days after removal of DaRT seeds. | Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic tissue present in the remaining tumor tissue surgically removed 15-30 days after removal of DaRT seeds. |
Countries
Italy
Outcome results
None listed