Clinical trial NCT04363892: Combined Optical and Infrared Imaging for Early Prediction of Erythema During Breast and Chestwall Radiotherapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 7
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Establish the correlation between optical and IR skin imaging and skin toxicity
timeFrame: Week one of radiation treatment
measure: Establish the correlation between optical and IR skin imaging and skin toxicity
timeFrame: Week two of radiation treatment
measure: Establish the correlation between optical and IR skin imaging and skin toxicity
timeFrame: Week three of radiation treatment
measure: Establish the correlation between optical and IR skin imaging and skin toxicity
timeFrame: Week four of radiation treatment
measure: Establish the correlation between optical and IR skin imaging and skin toxicity
timeFrame: Week five of radiation treatment
Secondary outcomes:
measure: Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
timeFrame: Week one of radiation treatment
measure: Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
timeFrame: Week two of radiation treatment
measure: Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
timeFrame: Week three of radiation treatment
measure: Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
timeFrame: Week four of radiation treatment
measure: Establish the correlation between optical and IR skin imaging and skin itchiness and pain.
timeFrame: Week five of radiation treatment
measure: Establish the correlation between optical and IR skin and Quality Of Life (QOL).
timeFrame: Week one of radiation treatment.
measure: Establish the correlation between optical and IR skin and Quality Of Life (QOL).
timeFrame: Week five of radiation treatment.
measure: Establish the correlation between optical and IR skin and Quality Of Life (QOL).
timeFrame: Week six, follow-up after treatment.
measure: Establish the correlation between optical and IR skin and Quality Of Life (QOL).
timeFrame: Week seven, follow-up after treatment.
measure: Establish the correlation between optical and IR skin and Quality Of Life (QOL).
timeFrame: Week eight, follow-up after treatment.
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University - Radiation Oncology Department
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Michele Svatos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
citation: Formenti SC, Gidea-Addeo D, Goldberg JD, Roses DF, Guth A, Rosenstein BS, DeWyngaert KJ. Phase I-II trial of prone accelerated intensity modulated radiation therapy to the breast to optimally spare normal tissue. J Clin Oncol. 2007 Jun 1;25(16):2236-42. doi: 10.1200/JCO.2006.09.1041. Epub 2007 Apr 30.