Combined Optical and Infrared Imaging for Early Prediction of Erythema During Breast and Chestwall Radiotherapy
August 19, 2024 updated by: Nova Scotia Health Authority
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
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 4H7
- Dalhousie University - Radiation Oncology Department
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
|
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
Time Frame: Week one 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.
|
Week one of radiation treatment
|
|
Establish the correlation between optical and IR skin imaging and skin toxicity
Time Frame: Week two 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.
|
Week two of radiation treatment
|
|
Establish the correlation between optical and IR skin imaging and skin toxicity
Time Frame: Week three 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.
|
Week three of radiation treatment
|
|
Establish the correlation between optical and IR skin imaging and skin toxicity
Time Frame: Week four 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.
|
Week four of radiation treatment
|
|
Establish the correlation between optical and IR skin imaging and skin toxicity
Time Frame: 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.
|
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.
Time Frame: Week one of radiation treatment
|
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.
Time Frame: Week two of radiation treatment
|
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.
Time Frame: Week three of radiation treatment
|
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.
Time Frame: Week four of radiation treatment
|
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.
Time Frame: Week five of radiation treatment
|
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).
Time Frame: Week one of radiation treatment.
|
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).
Time Frame: Week five of radiation treatment.
|
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).
Time Frame: Week six, follow-up after treatment.
|
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).
Time Frame: Week seven, follow-up after treatment.
|
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).
Time Frame: Week eight, follow-up after treatment.
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michele Svatos, PhD, Dalhousie University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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