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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05294120
Collaborator
Physical Sciences Inc. (Other)
32
Enrollment
1
Location
1
Arm
11.9
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to find out if radiation therapy (RT) guided by the new reflectance confocal microscopy (RCM)/optimal 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided
  • Radiation: Radiation Therapy
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a prospective, open-label, single-center, phase II, single-arm clinical trial.This is a prospective, open-label, single-center, phase II, single-arm clinical trial.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation TherapY: CLARITY
Actual Study Start Date :
Mar 3, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. frequency and severity of adverse events [up to 12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • ≥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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • Physical Sciences Inc.

Investigators

  • Principal Investigator: Christopher Barker, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT05294120
Other Study ID Numbers:
  • 20-553
First Posted:
Mar 24, 2022
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Radiation Therapy
Reflectance Confocal Microscopy (RCM)/Optimal Coherence Tomography (OCT)
20-553
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell

Study Results

No Results Posted as of Mar 25, 2022