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

Study Overview
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Brief Summary
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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.

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

Conditions
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Basal Cell Carcinoma

Intervention / Treatment
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* Device: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided
* Radiation: Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, open-label, single-center, phase II, single-arm clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy<br>If eligible, patients will undergo pretreatment RCM/OCT imaging, followed by RT. Six weeks after the completion of RT, patients will undergo post-treatment assessment with RCM/OCT and biopsy. If residual carcinoma is detected on the biopsy, surgical excision of the BCC will be performed. If no residual carcinoma is detected on the biopsy, the patient will be monitored for clinical evidence of recurrence for up to 3 years. | Device: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided<br>* Patients will undergo RCM/OCT with an imaging specialist in the Dermatology Service. This is not expected to take longer than 30 minutes. Prior to imaging, a digital photograph will be taken of the biopsy proven BCC.<br>Radiation: Radiation Therapy<br>* After the completion of skin imaging, patients will undergo simulation and tumor radiotherapy. An equivalent total dose in 2 Gy fractions (EQD2) of 45-46 Gy will be delivered for treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histologic tumor response rate | The presence of residual carcinoma on a biopsy or surgical excision specimen will be primary determinant for the primary endpoint outcome. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency and severity of adverse events | by the Common Terminology and Criteria for Adverse Events, version 5.0 | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation Therapy, Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT), 20-553