NCT04013711已完成不适用
Quantitative Thermal Imaging to Evaluate Skin Toxicity From Radiation Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Temperature changes in skin during radiotherapy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Temperature changes in skin during radiotherapy.
时间窗: 1 year
To measure the temperature changes in skin during each week of radiation therapy and correlate to radiotherapy treatment time.
次要结局
- Measure patient-reported toxicity using a validated self-assessment tool (Dermatology Quality of Life Questionnaire)(1 year)
研究者
Dr. William Tran
Clinical scientist
Sunnybrook Health Sciences Centre
研究点 (2)
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