Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy

Quantitative Thermal Imaging to Evaluate Skin Toxicity From Radiation Treatment

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.

Study Overview

• Status: Completed
• Conditions: Radiodermatitis; Radiotherapy Side Effect
• Intervention / Treatment: Diagnostic test: Thermography

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. Subjects must give appropriate written informed consent prior to participation in the study
3. Subjects must be able and willing to comply and understand the instructions associated with the imaging procedure.
4. Both men and women are eligible for participation
5. Subjects must be at least 18 years of age

6. Subjects must be receiving radiotherapy:

   1. adjuvant radiotherapy to the whole breast or chest wall, or;
   2. in the case of head and neck treatment, either as definitive treatment or adjuvantly.
7. definitive radiotherapy of the head and neck

Exclusion Criteria:

1. Subjects with any pre-existing dermatologic abnormalities (open sores, keloids, psoriasis) involving the treated breast or head and neck.
2. Patients with very hairy skin surface (this does not permit measuring the heat output)
3. Subjects with a current or past medical history of connective tissue disease.
4. Subjects who are pregnant or lactating (which usually preclude them from radiotherapy)
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermal Imaging; 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.	Diagnostic test: Thermography; Thermograms will be acquired of both treated and non-treated cancer site for comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure patient-reported toxicity using a validated self-assessment tool (Dermatology Quality of Life Questionnaire)	Measure patient-reported symptoms using a validated questionnaire.	1 year

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: William T Tran, PhD, Clinician Scientist

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): July 19, 2022

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Dermatitis; Radiation Injuries; Radiodermatitis
• Other Study ID Numbers: 187-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No