NCT05294120

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DEVICE	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.
RADIATION	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.

Timeline

• Start date: 2022-03-03
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-03-24
• Last updated: 2025-04-18

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study