The Use of 3D Surface Imaging in the Objective Assessment of Breast Conserving Therapy

NCT02304614 | Unknown

• 1 other identifier: CCR4252
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

3D surface imaging has been used in the objective evaluation of cosmetic outcome of oncoplastic procedures such as breast reconstruction and lipofilling, however there is only one article published relating to Breast Conserving Therapy (BCT). The aim of this study is to assess the use 3D surface imaging as a tool in the assessment of symmetry of outcome following breast conserving therapy. The results of the surface imaging will be correlated with patient satisfaction, using the BREAST-Q, which is a validated patient questionnaire and correlated with panel assessment by an independent panel of two surgeons, one clinical oncologist and one breast care nurse.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• A multivariate model using clinical risk factors to predict percentage volume asymmetry

  measured on day of imaging

Secondary Outcomes (4)

• Comparison of panel assessment of the symmetry of outcome of BCT by independent clinicians using 2D and 3D photography with patient reported outcome using satisfaction with breasts domain of the breast conservation module of the BREAST-Q

  measured on day of imaging

• Establishment of the most reproducible method to measure focal deficits using 3D surface imaging

  measured on day of imaging

• Comparison of the volume measurements in women who have undergone BCT as measured by VECTRA XT (non portable 3D surface imaging device) and VECTRA H1 (portable 3D surface imaging device)

  measured on day of imaging

• Comparison of compressibility of treated and untreated breasts as measured by applanation tonometry

  measured on day of imaging

Study Arms (1)

Group 1

Patients who have undergone Breast conserving Therapy

Other: 3D surface imaging using a non portable and portable camera; Other: Patient reported outcome measure (PROM): BREAST-Q; Other: 2D photography; Other: Applanation Tonometry

Interventions

3D surface imaging using a non portable and portable camera OTHER

The participant will have 3D surface imaging taken of their breasts (the face will not be shown)

Also known as: 3D photography

Group 1

Patient reported outcome measure (PROM): BREAST-Q OTHER

The participant will answer the BREAST-Q questionnaire. This is a patient reported outcome measurement of satisfaction and quality of life after BCT

Group 1

2D photography OTHER

The participant will have standard medical photography of their breasts (the face will not be shown)

Also known as: medical photography

Group 1

Applanation Tonometry OTHER

A small 300g disc is placed on the breast to measure the surface area of contact with the breast to measure compressibility

Also known as: Measurement of breast compressibility

Group 1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone Breast Conserving Therapy at least one year ago

You may qualify if:

• Female patients
• No age limit
• underwent unilateral breast conserving surgery at The Royal Marsden NHS Foundation Trust (RMH)
• underwent adjuvant whole breast radiotherapy at RMH
• attending for their annual surveillance mammogram
• between one and five and half years after surgery (rounded to nearest whole year)

You may not qualify if:

• undergone surgery to the contralateral breast (breast conserving surgery, symmetrisation or mastectomy)
• undergone further surgery to the affected breast subsequent to BCT (eg lipofilling or other reconstruction).
• unable to stand for long enough to have clinical photos (approximately 10 minutes)
• unable to answer the BREAST-Q questionaire (e.g. learning difficulties)

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Jennifer E Rusby, DM FRCS

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 2, 2014
• Study Start: April 1, 2015
• Primary Completion: March 22, 2017
• Study Completion: December 24, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

GB (1)