Status:
COMPLETED
Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Radiotherapy Side Effect
Radiodermatitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 d...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04013711
Start Date
August 1 2018
End Date
July 19 2022
Last Update
April 11 2023
Active Locations (1)
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1
Sunnybrook Hospital
Toronto, Ontario, Canada, M4N 3M5