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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Basal Cell Carcinoma

Treatments: Radiation: Radiation Therapy; Device: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided

Study type: Interventional

Funder types: Other

Identifiers

NCT05294120

20-553

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy

Experimental group

Description:

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.

Treatment:

Radiation: Radiation Therapy

Device: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided