A Phase 2 interventional study of Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided and Radiation Therapy in Basal Cell Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
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.
364 studies on the registry are indexed under Carcinoma, Basal Cell; 66 are open to participants now.
This study's enrollment of 38 is close to the median of 41 across 258 interventional studies indexed under Carcinoma, Basal Cell.
Browse Carcinoma, Basal Cell studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Amenable to RCM/OCT and radiation therapy in opinion of investigator
Exclusion Criteria:
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 · Radiation: Radiation Therapy
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.
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.
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.
Time frame: 6 weeks
frequency and severity of adverse events
by the Common Terminology and Criteria for Adverse Events, version 5.0
Time frame: up to 12 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center