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NCT Number: NCT05294120

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided

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

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.

Primary outcomes

  1. histologic tumor response rate

    Time frame: 6 weeks

    The presence of residual carcinoma on a biopsy or surgical excision specimen will be primary determinant for the primary endpoint outcome.

Secondary outcomes

  1. frequency and severity of adverse events

    Time frame: up to 12 weeks

    by the Common Terminology and Criteria for Adverse Events, version 5.0

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Physical Sciences Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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