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

Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05294120
• Other study ID #: 20-553
• Status: Recruiting
• Phase: Phase 2
• Start date: March 3, 2022
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Christopher Barker, MD
• Phone: 212-639-8168
• Email: lianm[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Device:
• Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided
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:
• Radiation Therapy
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	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 Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
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

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Physical Sciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	frequency and severity of adverse events	by the Common Terminology and Criteria for Adverse Events, version 5.0	up to 12 weeks

External Links

•   Memorial Sloan Kettering Cancer Center