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

NCT05294120 | Active Not Recruiting Phase 2 FDA Device

• 1 other identifier: 20-553
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Radiation Therapy; Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT); 20-553

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (1)

• frequency and severity of adverse events

  up to 12 weeks

Study Arms (1)

Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy

EXPERIMENTAL

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

Interventions

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.

Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy

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.

Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• ≥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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Physical Sciences Inc.: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Christopher Barker, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: March 3, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7)