跳至主要内容
临床试验/NCT04363892
NCT04363892终止不适用

A Prospective Cohort Clinical Trial to Assess the Skin Imaging Spectral and Morphological Changes During Breast Adjuvant Radiotherapy as an Early Predictor of Acute Skin Toxicities

Nova Scotia Health Authority2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
2
主要终点
Establish the correlation between optical and IR skin imaging and skin toxicity

研究概览

简要总结

The aim of this study is to develop a computer model, based on photographs and heat images of patients' skin, to provide early prediction of painful reddening of the skin during radiotherapy treatment.

详细描述

There is currently no reliable tool to quantify and detect erythema of the skin during radiotherapy. This side-effect may lead to painful moist desquamation, and eventually permanent delayed side effects like telangiectasia. If such a tool would be available, several interventions could be staged, including (1) the use of steroid cream], (2) the re-simulation and/or re-planning of patients to decrease the skin dose by spreading out the entrance of the beams, (3) adjusting or eliminating the use of bolus on the skin surface (which boosts superficial dose) or (4) the use of other treatment techniques including prone technique.

Given that the dose delivered is not a reliable metric to predict for erythema in a given patient, a new method for monitoring, staging and ultimately predicting skin response is needed. By analyzing images of the skin using both visible and infrared spectral regions, and by carefully converting the information in the images to quantitative metrics, it may be possible to characterize the stage of a patient's response to radiation, and to understand which patients may go on to experience chronic pain, severe burns or other more serious side effects while it is still early enough to intervene.

The proposed research is to develop a software model that will take as input patient skin image data and the patient known clinical outcomes and algorithmically generalize a model to predict a biological response of skin to ionizing radiation for any future patient, after a few initial images.

In the first stage of this study, the data will be aggregated to devise the dose response curve. In later phases, the model will be refined and used for predictive purposes, i.e., once a new patient has begun radiotherapy sessions, their initial response will be quantified, and fed into the model to predict the skin response endpoint after the course of radiation therapy ends. As mentioned, this information could be used to adapt the radiation course and optimize the therapy for the individual, potentially preventing morbidity from overdose, or risk of recurrence from under dose.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • All female patients referred for adjuvant radiotherapy following breast conserving surgery/mastectomy.

排除标准

  • Patients with known skin issues (e.g. dermatomyositis, rosacea)
  • Patients with excessive risk of skin recurrence, including T4d
  • Patients with locally advanced breast cancer.

结局指标

主要结局

Establish the correlation between optical and IR skin imaging and skin toxicity

时间窗: Week five of radiation treatment

Acute skin side effects assessed using the National Cancer Institute of Canada Common Terminology Criteria for Adverse Events, version 4.03. Scale ranges from 1 to 5. Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.

次要结局

  • Establish the correlation between optical and IR skin imaging and skin itchiness and pain.(Week five of radiation treatment)
  • Establish the correlation between optical and IR skin and Quality Of Life (QOL).(Week eight, follow-up after treatment.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验