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

NCT02131805 | Completed

• 1 other identifier: 14-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 8

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.

Conditions

Cutaneous Basal Cell; Squamous Cell Carcinoma

Keywords

skin; Brachytherapy; 14-001

Outcome Measures

Primary Outcomes (2)

• efficacy of Electronic Skin Surface Brachytherapy (ESSB)

  Efficacy will be measured by local control of the irradiated BCC/SCC three years after brachytherapy.

  3 years

• assess the cosmetic outcome of ESSB

  Cosmetic outcome will be patient-reported and clinician-assessed after brachytherapy.

  3 years

Secondary Outcomes (2)

• severity of adverse events

  3 years

• reported quality of life

  3 years

Study Arms (1)

Electronic Skin Surface Brachytherapy

EXPERIMENTAL

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

Interventions

Quality of life assessment BEHAVIORAL

Electronic Skin Surface Brachytherapy

Electronic Skin Surface Brachytherapy RADIATION

Electronic Skin Surface Brachytherapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Lynn Cancer Institute: collaborator

Study Sites (8)

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Study Officials

• Christopher Barker, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 6, 2014
• Study Start: May 1, 2014
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (8)