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

Phase 2

Active, not recruiting

• Conditions: Basal Cell Carcinoma
• Interventions: Device: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided; Radiation: Radiation Therapy

• Registration Number: NCT05294120
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-03
• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-18
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy	Radiation Therapy	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.
Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy	Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided	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.

Primary Outcome Measures

Name	Time	Method
histologic tumor response rate	6 weeks	The presence of residual carcinoma on a biopsy or surgical excision specimen will be primary determinant for the primary endpoint outcome.

Secondary Outcome Measures

Name	Time	Method
frequency and severity of adverse events	up to 12 weeks	by the Common Terminology and Criteria for Adverse Events, version 5.0

Trial Locations

Locations (7)

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

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