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OpenTrials
Completed

NCT Number: NCT04013711

Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thermography

Diagnostic Test

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

Primary outcomes

  1. Temperature changes in skin during radiotherapy.

    Time frame: 1 year

    To measure the temperature changes in skin during each week of radiation therapy and correlate to radiotherapy treatment time.

Secondary outcomes

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

    Time frame: 1 year

    Measure patient-reported symptoms using a validated questionnaire.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

Quantitative Thermal Imaging to Evaluate Skin Toxicity From Radiation Treatment

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jul 10, 2019
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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