Thermal Imaging to Evaluate Skin Toxicity From Radiotherapy

NCT ID: NCT04013711

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2022-07-19

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.

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.

Conditions

Radiotherapy Side Effect; Radiodermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Thermography

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Thermography

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. William Tran

Clinical scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William T Tran, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinician Scientist

Locations

Sunnybrook Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

187-2018

Identifier Type: -

Identifier Source: org_study_id