Combined Optical and Infrared Imaging for Early Prediction of Erythema During Breast and Chestwall Radiotherapy

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Optical and infrared imaging

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 4H7
      • Dalhousie University - Radiation Oncology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Receiving optical and infrared imaging; This is the only arm of the study. All patients will have optical and infrared images acquired of skin on the treated and contralateral sides.	Other: Optical and infrared imaging; Acquiring images (photographs) of the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish the correlation between optical and IR skin imaging and skin toxicity	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.	Week one of radiation treatment
Establish the correlation between optical and IR skin imaging and skin toxicity	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.	Week two of radiation treatment
Establish the correlation between optical and IR skin imaging and skin toxicity	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.	Week three of radiation treatment
Establish the correlation between optical and IR skin imaging and skin toxicity	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.	Week four of radiation treatment
Establish the correlation between optical and IR skin imaging and skin toxicity	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.	Week five of radiation treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.	Weekly quantitative visual analog scale (VAS) measures of itchiness and/or pain Scale ranges from 0 (no itchiness or pain) to 10 (extreme itchiness or pain). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.	Week one of radiation treatment
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.	Weekly quantitative visual analog scale (VAS) measures of itchiness and/or pain Scale ranges from 0 (no itchiness or pain) to 10 (extreme itchiness or pain). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.	Week two of radiation treatment
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.	Weekly quantitative visual analog scale (VAS) measures of itchiness and/or pain Scale ranges from 0 (no itchiness or pain) to 10 (extreme itchiness or pain). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.	Week three of radiation treatment
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.	Weekly quantitative visual analog scale (VAS) measures of itchiness and/or pain Scale ranges from 0 (no itchiness or pain) to 10 (extreme itchiness or pain). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.	Week four of radiation treatment
Establish the correlation between optical and IR skin imaging and skin itchiness and pain.	Weekly quantitative visual analog scale (VAS) measures of itchiness and/or pain Scale ranges from 0 (no itchiness or pain) to 10 (extreme itchiness or pain). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.	Week five of radiation treatment
Establish the correlation between optical and IR skin and Quality Of Life (QOL).	The European Organization for Research in Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and -BR23 will be used (30 questions, scale of 1 to 4). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.	Week one of radiation treatment.
Establish the correlation between optical and IR skin and Quality Of Life (QOL).	The European Organization for Research in Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and -BR23 will be used (30 questions, scale of 1 to 4). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.	Week five of radiation treatment.
Establish the correlation between optical and IR skin and Quality Of Life (QOL).	The European Organization for Research in Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and -BR23 will be used (30 questions, scale of 1 to 4). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.	Week six, follow-up after treatment.
Establish the correlation between optical and IR skin and Quality Of Life (QOL).	The European Organization for Research in Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and -BR23 will be used (30 questions, scale of 1 to 4). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.	Week seven, follow-up after treatment.
Establish the correlation between optical and IR skin and Quality Of Life (QOL).	The European Organization for Research in Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and -BR23 will be used (30 questions, scale of 1 to 4). Correlation will be performed relative to optical image colour, texture, and temperature reflected by IR imaging.	Week eight, follow-up after treatment.

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Michele Svatos, PhD, Dalhousie University

Publications and helpful links

General Publications

• 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.
• Archambeau JO, Pezner R, Wasserman T. Pathophysiology of irradiated skin and breast. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1171-85. doi: 10.1016/0360-3016(94)00423-I.
• Bentzen SM, Overgaard M. Relationship between early and late normal-tissue injury after postmastectomy radiotherapy. Radiother Oncol. 1991 Mar;20(3):159-65. doi: 10.1016/0167-8140(91)90092-u.
• Pignol JP, Olivotto I, Rakovitch E, Gardner S, Sixel K, Beckham W, Vu TT, Truong P, Ackerman I, Paszat L. A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol. 2008 May 1;26(13):2085-92. doi: 10.1200/JCO.2007.15.2488. Epub 2008 Feb 19.
• Pignol JP, Truong P, Rakovitch E, Sattler MG, Whelan TJ, Olivotto IA. Ten years results of the Canadian breast intensity modulated radiation therapy (IMRT) randomized controlled trial. Radiother Oncol. 2016 Dec;121(3):414-419. doi: 10.1016/j.radonc.2016.08.021. Epub 2016 Sep 13.
• Ishiyama H, Niino K, Hosoya T, Hayakawa K. Results of a questionnaire survey for symptom of late complications caused by radiotherapy in breast conserving therapy. Breast Cancer. 2006;13(2):197-201. doi: 10.2325/jbcs.13.197.
• 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.
• Pignol JP, Vu TT, Mitera G, Bosnic S, Verkooijen HM, Truong P. Prospective evaluation of severe skin toxicity and pain during postmastectomy radiation therapy. Int J Radiat Oncol Biol Phys. 2015 Jan 1;91(1):157-64. doi: 10.1016/j.ijrobp.2014.09.022. Erratum In: Int J Radiat Oncol Biol Phys. 2015 Jul 1;92(3):702. doi: 10.1016/j.ijrobp.2015.02.049.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): June 14, 2021
• Study Completion (Actual): June 14, 2021

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RadOnc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No