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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02131805
Recruitment Status : Active, not recruiting
First Posted : May 6, 2014
Last Update Posted : April 19, 2022
Lynn Cancer Institute
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cutaneous Basal Cell Squamous Cell Carcinoma Radiation: Electronic Skin Surface Brachytherapy Behavioral: Quality of life assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Pilot Study of Electronic Skin Surface Brachytherapy for Cutaneous Basal Cell and Squamous Cell Carcinoma
Actual Study Start Date : May 2014
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

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

Primary Outcome Measures :
  1. 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.

  2. assess the cosmetic outcome of ESSB [ Time Frame: 3 years ]
    Cosmetic outcome will be patient-reported and clinician-assessed after brachytherapy.

Secondary Outcome Measures :
  1. 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.

  2. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02131805

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United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, United States, 11553
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Lynn Cancer Institute
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Principal Investigator: Christopher Barker, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT02131805    
Other Study ID Numbers: 14-001
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell