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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-03

Study Completion Date

2026-03-31

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.

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Detailed Description

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Conditions

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Basal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a prospective, open-label, single-center, phase II, single-arm clinical trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy

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.

Group Type EXPERIMENTAL

Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided

Intervention Type DEVICE

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.

Radiation Therapy

Intervention Type RADIATION

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.

Interventions

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Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided

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.

Intervention Type DEVICE

Radiation Therapy

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.

Intervention Type RADIATION

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No