Back to resultsThermal Imaging to Evaluate Skin Toxicity From Radiotherapy
Primary Purpose
Radiotherapy Side Effect, Radiodermatitis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Thermography
Sponsored by
About this trial
This is an interventional diagnostic trial for Radiotherapy Side Effect
Eligibility Criteria
Inclusion Criteria:
- Biopsy-confirmed diagnosis of breast cancer (Stage 0-III) or head and neck cancer (all subtypes; stage I - IV) according to American Joint Committee on Cancer staging criteria.
- Subjects must give appropriate written informed consent prior to participation in the study
- Subjects must be able and willing to comply and understand the instructions associated with the imaging procedure.
- Both men and women are eligible for participation
- Subjects must be at least 18 years of age
Subjects must be receiving radiotherapy:
- adjuvant radiotherapy to the whole breast or chest wall, or;
- in the case of head and neck treatment, either as definitive treatment or adjuvantly.
- definitive radiotherapy of the head and neck
Exclusion Criteria:
- Subjects with any pre-existing dermatologic abnormalities (open sores, keloids, psoriasis) involving the treated breast or head and neck.
- Patients with very hairy skin surface (this does not permit measuring the heat output)
- Subjects with a current or past medical history of connective tissue disease.
- Subjects who are pregnant or lactating (which usually preclude them from radiotherapy)
- Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety, history of musculoskeletal disease which may predispose them to discomfort during the imaging/scanning period.
Sites / Locations
- Sunnybrook Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thermal Imaging
Arm Description
Patients will undergo non-invasive, thermal imaging of their whole breast or head and neck cancer site, during the course of the radiotherapy treatment, at weekly time intervals.
Outcomes
Primary Outcome Measures
Temperature changes in skin during radiotherapy.
To measure the temperature changes in skin during each week of radiation therapy and correlate to radiotherapy treatment time.
Secondary Outcome Measures
Measure patient-reported toxicity using a validated self-assessment tool (Dermatology Quality of Life Questionnaire)
Measure patient-reported symptoms using a validated questionnaire.
Full Information
NCT ID
NCT04013711
First Posted
October 15, 2018
Last Updated
April 10, 2023
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT04013711
Brief Title
Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy
Official Title
Quantitative Thermal Imaging to Evaluate Skin Toxicity From Radiation Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
July 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A significant proportion of patients treated with whole-breast or head and neck radiotherapy will experience skin toxicity, i.e. skin dermatitis, which may lead to erythema, dry desquamation and wet desquamation. It is hypothesized that quantitative thermal imaging can be used to measure radiation-induced skin toxicity.
Detailed Description
The aim of this study is to use quantitative thermal imaging to evaluate skin toxicity in patients treated with whole-breast or head and neck radiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotherapy Side Effect, Radiodermatitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thermal Imaging
Arm Type
Experimental
Arm Description
Patients will undergo non-invasive, thermal imaging of their whole breast or head and neck cancer site, during the course of the radiotherapy treatment, at weekly time intervals.
Intervention Type
Diagnostic Test
Intervention Name(s)
Thermography
Intervention Description
Thermograms will be acquired of both treated and non-treated cancer site for comparison.
Primary Outcome Measure Information:
Title
Temperature changes in skin during radiotherapy.
Description
To measure the temperature changes in skin during each week of radiation therapy and correlate to radiotherapy treatment time.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Measure patient-reported toxicity using a validated self-assessment tool (Dermatology Quality of Life Questionnaire)
Description
Measure patient-reported symptoms using a validated questionnaire.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Biopsy-confirmed diagnosis of breast cancer (Stage 0-III) or head and neck cancer (all subtypes; stage I - IV) according to American Joint Committee on Cancer staging criteria.
Subjects must give appropriate written informed consent prior to participation in the study
Subjects must be able and willing to comply and understand the instructions associated with the imaging procedure.
Both men and women are eligible for participation
Subjects must be at least 18 years of age
Subjects must be receiving radiotherapy:
adjuvant radiotherapy to the whole breast or chest wall, or;
in the case of head and neck treatment, either as definitive treatment or adjuvantly.
definitive radiotherapy of the head and neck
Exclusion Criteria:
Subjects with any pre-existing dermatologic abnormalities (open sores, keloids, psoriasis) involving the treated breast or head and neck.
Patients with very hairy skin surface (this does not permit measuring the heat output)
Subjects with a current or past medical history of connective tissue disease.
Subjects who are pregnant or lactating (which usually preclude them from radiotherapy)
Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety, history of musculoskeletal disease which may predispose them to discomfort during the imaging/scanning period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William T Tran, PhD
Organizational Affiliation
Clinician Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy
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