Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Radiotherapy Side Effect; Radiodermatitis

Treatments: Diagnostic Test: Thermography

Study type: Interventional

Funder types: Other

Identifiers

NCT04013711

187-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Thermal Imaging

Experimental group

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.

Treatment:

Diagnostic Test: Thermography