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

NCT04363892 | Terminated DMC

• 1 other identifier: RadOnc
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Establish the correlation between optical and IR skin imaging and skin itchiness and pain.

  Week one of radiation treatment

• Establish the correlation between optical and IR skin imaging and skin itchiness and pain.

  Week two of radiation treatment

• Establish the correlation between optical and IR skin imaging and skin itchiness and pain.

  Week three of radiation treatment

• Establish the correlation between optical and IR skin imaging and skin itchiness and pain.

  Week four of radiation treatment

• Establish the correlation between optical and IR skin imaging and skin itchiness and pain.

  Week five of radiation treatment

Study Arms (1)

Receiving optical and infrared imaging

EXPERIMENTAL

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

Interventions

Optical and infrared imaging OTHER

Acquiring images (photographs) of the skin

Receiving optical and infrared imaging

Eligibility Criteria

• Gender Eligibility Details: Study relates to female breast cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Dalhousie University - Radiation Oncology Department

Halifax, Nova Scotia, B3H 4H7, Canada

Location

Related Publications (8)

• 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.

  PMID: 7713781 BACKGROUND

• 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.

  PMID: 1852907 BACKGROUND

• 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.

  PMID: 25835623 BACKGROUND

• 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.

  PMID: 18285602 BACKGROUND

• 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.

  PMID: 27637858 BACKGROUND

• 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.

  PMID: 16755117 BACKGROUND

• 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.

  PMID: 12393820 BACKGROUND

• 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.

  PMID: 17470849 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michele Svatos, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 27, 2020
• Study Start: July 1, 2020
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)