Electronic Brachytherapy for the Treatment of NMSC

Primary basal cell and primary squamous cell carcinomas

Inclusion Criteria:

• Patient has signed the informed consent form
• Pathological diagnosis confirmed of squamous cell or basal cell carcinoma
• Histopathological Grade: G1 (well differentiated), G2 (moderately differentiated), or Gx (Not assessed in report)
• Clinical Staging Tis, T1, or T2 (Must be ≤ 4 cm in diameter)
• One lesion is treated, or more than 1 lesion is treated with a minimum of a 5 mm gap between the edges of the lesion margins.

Exclusion Criteria:

• T2 > 4 cm and T3 and T4
• American Joint Committee Staging for NMSC Stages III and IV
• Histopathologic Grade 3 (poorly differentiated) or higher grade
• Target area is adjacent to a burn scar
• Target area is on the lip
• Patient < 50 years of age
• Any prior definitive surgical resection of the cancer
• Perineural invasion
• Lesion depth > 5mm on clinical assessment or as assessed by ultrasound or CT.
• Patient is pregnant (pregnancy test required if standard of care).
• Target area is prone to trauma.
• Target area with compromised lymphatic or vascular drainage.
• Participation in another investigational device or drug study concurrently.
• Patient has undergone prior radiation therapy to this specific anatomic location.
• Patient is receiving pharmacologic agent(s) at or around the time of the Radiation therapy that is/are known to produce skin reactions that will influence cosmesis grading during study.
• Patient is receiving chemotherapeutic agent(s) Six (6) weeks before or six (6) weeks after radiation therapy.
• Life expectancy less than five (5) years.