Basal Cell Carcinoma, Squamous Cell Carcinoma of the Skin
Conditions
Keywords
radiation, brachytherapy, skin cancer
Brief summary
This is a pilot study to determine the usefulness of new brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit basal cell and squamous cell carcinoma patients by providing conformal radiation therapy to the surface of the skin.
Interventions
DEVICECivaDerm
radioactive bandage
Sponsors
CivaTech Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subject signed informed consent * Confirmed superficial or nodular basal cell or squamous cell carcinoma * Biopsy proven on chest, stomach, back, arms, legs, feet (trunk and extremities) * \>5 mm of residual tumor * tumors \< 3 cm * Capable of complying with Patient Release Instructions
Exclusion criteria
* Is unable or unwilling to comply with the protocol requirements * Pregnant or breast feeding * Metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| skin toxicity events | within 2 months of treatment | grade 3+ events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| dose delivered to target | 1 week | calculated radiation dose |
Countries
United States
Outcome results
None listed