Squamous Cell Carcinoma
Conditions
Keywords
Squamous Cell Carcinoma, Alpha emitting radiation, Skin Cancer, Carcinoma, Squamous, HNSCC
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).
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 30-45 days post seed insertion | The incidence, severity and frequency of all Adverse Events |
| Reduction in Tumor size | 30-45 days post seed insertion | The reduction in tumor size 30-45 days after DaRT insertion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of NecroticTissue | 30-45 days post seed insertion | Percent of necrotic tissue in the tumor 30 days after DaRT insertion |
Countries
Israel
Outcome results
None listed