Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Royal Marsden NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02304614
First received: November 27, 2014
Last updated: March 31, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Breast Cancer
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Use of 3D Surface Imaging in the Objective Assessment of Breast Conserving Therapy

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • A multivariate model using clinical risk factors to predict percentage volume asymmetry [ Time Frame: measured on day of imaging ]

Secondary Outcome Measures:
  • 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 [ Time Frame: measured on day of imaging ]
  • Establishment of the most reproducible method to measure focal deficits using 3D surface imaging [ Time Frame: 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) [ Time Frame: measured on day of imaging ]
  • Comparison of compressibility of treated and untreated breasts as measured by applanation tonometry [ Time Frame: measured on day of imaging ]

Estimated Enrollment: 300
Actual Study Start Date: April 1, 2015
Estimated Study Completion Date: March 24, 2018
Estimated Primary Completion Date: April 24, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Patients who have undergone Breast conserving Therapy
Other: 3D surface imaging using a non portable and portable camera
The participant will have 3D surface imaging taken of their breasts (the face will not be shown)
Other Name: 3D photography
Other: Patient reported outcome measure (PROM): BREAST-Q
The participant will answer the BREAST-Q questionnaire. This is a patient reported outcome measurement of satisfaction and quality of life after BCT
Other: 2D photography
The participant will have standard medical photography of their breasts (the face will not be shown)
Other Name: medical photography
Other: Applanation Tonometry
A small 300g disc is placed on the breast to measure the surface area of contact with the breast to measure compressibility
Other Name: Measurement of breast compressibility

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone Breast Conserving Therapy at least one year ago
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02304614

Contacts
Contact: Rachel L O'Connell, MBBS BSc MRCS 02086426011 ext 1282 roconnell@doctors.org.uk
Contact: Jennifer E Rusby, DM FRCS 02086426011 ext 4081 jennifer.rusby@rmh.nhs.uk

Locations
United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
London/Sutton, United Kingdom, SM2 5PT
Contact: Rachel L OConnell, MBBSBScMRCS    02086426011 ext 1282    roconnell@doctors.org.uk   
Contact: Jennifer E Rusby, DMFRCS    08026426011 ext 4081    jennifer.rusby@rmh.nhs.uk   
Sub-Investigator: Peter Barry         
Sub-Investigator: William Allum         
Sub-Investigator: Nandita deSouza         
Sub-Investigator: Anna Kirby         
Sub-Investigator: Nicky Roche         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Jennifer E Rusby, DM FRCS Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02304614     History of Changes
Other Study ID Numbers: CCR4252
Study First Received: November 27, 2014
Last Updated: March 31, 2017

ClinicalTrials.gov processed this record on April 21, 2017