Electronic Brachytherapy for Skin Cancer

Recruiting at 8 trial locations

Overseen By Michael Zelefsky, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Radiosensitizers, Radioprotectors

Disqualifiers: Recurrent BCC/SCC, Collagen vascular disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2-3 weeks

36 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Christopher Barker, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo electronic skin surface brachytherapy over six outpatient visits using the Nucletron's Esteya system

2-3 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety, cosmetic results, and quality of life, with follow-up lasting up to 5 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Electronic Skin Surface Brachytherapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Electronic Skin Surface Brachytherapy Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lynn Cancer Institute

Collaborator

Trials

2

Recruited

70+