A Study on Radiation Therapy Guided by the Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT) Device in People With Basal Cell Carcinoma

A Phase II Trial of Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation TherapY: CLARITY

The purpose of this study is to find out if radiation therapy (RT) guided by the new reflectance confocal microscopy (RCM)/optical coherence tomography (OCT) device is an effective treatment for basal cell carcinoma (BCC). The researchers will also look at the side effects from RT guided by the RCM/OCT device. In addition, will determine the quality of life before and after treatment by having the participant fill out questionnaires.

Inclusion Criteria:

• Biopsy proven basal cell carcinoma

  °Up to 3 tumors per patient can be treated per protocol synchronously or metachronously

• Clinical stage T1 or T2 by Union International to Control Cancer 8th edition system

  • ≤40 mm in maximum dimension
  • no deep invasion (beyond subcutaneous fat or >6 mm from granular later of dermis to deepest point of carcinoma)
  • no perineural invasion of nerves ≥0.1 mm diameter or deeper than dermis
  • no intraneural invasion
  • no bone erosion, invasion or foraminal transgression NOTE: For the purposes of protocol inclusion, if any of the features mentioned above is not included in the pathology report they will considered absent.

• ≥18 years old

• Amenable to RCM/OCT and radiation therapy in opinion of investigator

  • Some anatomic locations may preclude imaging by RCM/OCT may not be amenable to RCM/OCT imaging
  • Some medical comorbidities may preclude the delivery of radiation therapy (conditions rendering patients hypersensitive to ionizing radiation, or unable to undergo treatment)

• Able and willing to complete the Skindex 16 and Skin Cancer Index (must be able to understand English or Spanish)

Exclusion Criteria:

• Medical contraindication to radiation therapy in the opinion of the investigator
• Prior cancer radiotherapy which precludes the ability to safely deliver radiation therapy in the opinion of the investigator
• High likelihood of protocol non-compliance in the opinion of the investigator °Patients who demonstrate unwillingness to undergo protocol-defined treatment or follow-up procedures will be ineligible to participate