Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy

NCT04013711 | Completed DMC

• 1 other identifier: 187-2018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiotherapy Side Effect; Radiodermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measure patient-reported toxicity using a validated self-assessment tool (Dermatology Quality of Life Questionnaire)

  1 year

Study Arms (1)

Thermal Imaging

EXPERIMENTAL

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

Interventions

Thermography DIAGNOSTIC_TEST

Thermograms will be acquired of both treated and non-treated cancer site for comparison.

Thermal Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Radiation Injuries; Radiodermatitis

Interventions

Thermography

Condition Hierarchy (Ancestors)

Wounds and Injuries; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Thermometry; Investigative Techniques

Study Officials

• William T Tran, PhD

  Clinician Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical scientist

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: July 10, 2019
• Study Start: August 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: July 19, 2022
• Last Updated: April 11, 2023

Record last verified: 2022-02

Locations

CA (1)