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

Running, not enrolling · Phase 2

Conditions studied: Basal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT05294120

Run by

Memorial Sloan Kettering Cancer Center

People needed

38

Starts

2022-03-03

Expected to finish

2027-03-01

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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