Electronic Brachytherapy for Skin Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byChristopher Barker, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to assess the effectiveness of electronic skin surface brachytherapy (ESSB) for early stage basal or squamous cell carcinoma of the skin using a new device. This new device is Nucletron's Esteya Electronic Skin Surface Brachytherapy System. The investigators want to understand what effects, good and/or bad this device for delivering brachytherapy has on your skin cancer. The investigators also want to assess the safety, cosmetic results, the effects that ESSB has on quality of life and to correlate skin imaging with clinical response to ESSB.

Eligibility Criteria

This trial is for men and women over 60 with a life expectancy of at least 5 years, diagnosed with early stage basal or squamous cell carcinoma. Participants must be able to speak English, provide consent, have certain low-risk cancer features, and an ECOG performance status of 0-3. Those with previously treated cancers, diabetes that's poorly controlled, genetic disorders affecting skin or radiation response are excluded.

Inclusion Criteria

Ability to provide informed consent

I am 60 or older and expected to live 5 more years or longer.

My cancer is in the early stage and has not spread to lymph nodes or other parts.

+5 more

Exclusion Criteria

I have skin cancer in the same area where I previously had radiation.

My skin cancer is near or on a burn scar.

I have skin cancer in an area with poor blood or lymph flow.

+11 more

Participant Groups

The study tests the effectiveness of a new device called Esteya Electronic Skin Surface Brachytherapy System on treating early-stage skin cancer. It aims to evaluate the safety and cosmetic outcomes of this treatment as well as its impact on patients' quality of life.

1Treatment groups

Experimental Treatment

Group I: Electronic Skin Surface BrachytherapyExperimental Treatment2 Interventions

The patient will undergo quality of life assessment and skin imaging (ultrasonography and reflectance confocal microscopy). Brachytherapy will be performed over six outpatient visits over 2-3 weeks, on non-consecutive days. Patients will then be followed for 5 years. Reflectance confocal microscopy is optional for the participating sites.