Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma

September 19, 2023 updated by: Memorial Sloan Kettering Cancer Center

A Multicenter Pilot Study of Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Memorial Sloan Kettering Basking Ridge (Consent only)
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth (Consent only)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen (Consent only)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack (Consent only)
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester (All Protocol Activities)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau (Consent Only)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years
  • Histopathologic diagnosis of basal or squamous cell carcinoma

  • Clinical stage T1N0M0 (by AJCC 2010 criteria)

    °Basal cell carcinoma with morpheaform, sclerosing, mixed, infiltrative or micronodular features must be ≤1 cm

  • Low risk pathologic features (by AJCC 2010 criteria)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix C)
  • Able and willing to complete the Skindex16 and Skin Cancer Index (must be able to speak English)
  • Ability to provide informed consent

Exclusion Criteria:

  • BCC/SCC that was previously treated (ie, recurrent BCC/SCC)
  • BCC/SCC in region adjacent to or overlapping with region of prior radiotherapy
  • BCC/SCC on irregular surface (ie, target area not flat)
  • BCC/SCC adjacent to or overlapping with burn or scar
  • BCC/SCC in area prone to trauma (including, but not limited to the skin overlying the tibia, dorsum of hands and elbow)
  • BCC/SCC in area with compromised lymphatic drainage or vascular supply
  • BCC/SCC within 3 cm of another treated or untreated BCC/SCC
  • Inflammatory process in target area
  • Collagen vascular disease (lupus, scleroderma, rheumatoid arthritis)
  • Diabetes that is poorly controlled
  • Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans)
  • Receipt of treatment with another investigational device or drug
  • Receipt of drug that will affect biologic response to radiation (radiosensitizer or radioprotector)
  • High likelihood of protocol non-compliance (in opinion of investigator)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electronic Skin Surface Brachytherapy
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.
Radiation: Electronic Skin Surface Brachytherapy
Behavioral: Quality of life assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of Electronic Skin Surface Brachytherapy (ESSB)
Time Frame: 3 years
Efficacy will be measured by local control of the irradiated BCC/SCC three years after brachytherapy.
3 years
assess the cosmetic outcome of ESSB
Time Frame: 3 years
Cosmetic outcome will be patient-reported and clinician-assessed after brachytherapy.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
severity of adverse events
Time Frame: 3 years
(grade 1-4 adverse events). The study will use the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for assessing toxicity related to brachytherapy.
3 years
reported quality of life
Time Frame: 3 years
Patient reported health-related quality of life outcomes will be assessed using the Skindex-16 (Appendix A) and the Skin Cancer Index (Appendix B).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Lynn Cancer Institute

Investigators

  • Principal Investigator: Christopher Barker, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimated)

May 6, 2014

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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