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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

Primary Purpose

Basal Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided
Radiation Therapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring Radiation Therapy, Reflectance Confocal Microscopy (RCM)/Optimal Coherence Tomography (OCT), 20-553

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • ≥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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation TherapY

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

frequency and severity of adverse events
by the Common Terminology and Criteria for Adverse Events, version 5.0

Full Information

First Posted
March 15, 2022
Last Updated
February 28, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Physical Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05294120
Brief Title
A Study on Radiation Therapy Guided by the Reflectance Confocal Microscopy (RCM)/Optimal Coherence Tomography (OCT) Device in People With Basal Cell Carcinoma
Official Title
A Phase II Trial of Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation TherapY: CLARITY
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Physical Sciences Inc.

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
Keywords
Radiation Therapy, Reflectance Confocal Microscopy (RCM)/Optimal Coherence Tomography (OCT), 20-553

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, open-label, single-center, phase II, single-arm clinical trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation TherapY
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
histologic tumor response rate
Description
The presence of residual carcinoma on a biopsy or surgical excision specimen will be primary determinant for the primary endpoint outcome.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
frequency and severity of adverse events
Description
by the Common Terminology and Criteria for Adverse Events, version 5.0
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Barker, MD
Phone
212-639-8168
Email
lianm@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Rossi, MD
Phone
646-608-2311
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
Facility Name
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168
First Name & Middle Initial & Last Name & Degree
Anthony Rossi, MD
Phone
646-608-2311
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Barker, MD
Phone
212-639-8168

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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