Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02304614 |
| Other study ID # |
CCR4252 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2015 |
| Est. completion date |
December 24, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Royal Marsden NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
BCT is the most common breast surgical oncological procedure performed with approximately
28,500 patients undergoing this operation every year. In breast cancer surgery, the primary
aim of removing the cancer must be reconciled with the secondary aim of preserving breast
aesthetics. Objective analysis of cosmetic outcome measures in breast surgery has been
lacking, however 3D surface imaging is beginning to show promise in this area. Having a
robust tool for objective assessment of outcomes may facilitate critical appraisal of
techniques and therefore surgeon learning.
Currently the cosmetic success of an operation can be subjectively evaluated by patients' and
surgeons' visual assessment. Patient reported outcome measures (PROMs) are instruments to
measure any aspect of a patient's health status. Various PROMs have been used to evaluate
patients' satisfaction after breast cancer treatment. For example, the BREAST-Q was developed
quantitatively and qualitatively to measure patients' perceptions before and after breast
reconstruction by examining quality of life domains (psychosocial well-being, physical
well-being, sexual well-being) and satisfaction domains (satisfaction with breasts,
satisfaction with outcome, satisfaction with care). When using any of these PROMs, accuracy
and reproducibility are not measurable; the results are the subjective views of the patient.
While the patient opinion of her own appearance is clearly the most important outcome after
local oncological control, for the purposes of objective comparison between groups of
patients, surgeons and over time, independent clinicians (and / or lay people) may be
recruited to perform a 'panel assessment' of photographs in which the various aspects of
cosmesis such as breast shape, size and cleavage are considered in addition to overall
appearance. However such assessments are still subjective and often lack accuracy and
reproducibility.
There have been many attempts to derive objective measures of outcome. In the 1970's, Edstron
et al described 'split and reversed negatives' where photographic negatives of the left and
right breast were made and laid next to the non-negative right and left breast. The
constructed images of perfectly symmetrical breasts were compared with the original
photographs of the patients' breasts. More recently two software systems have been developed
to objectively evaluate the aesthetic surgical outcomes of breast surgery using 2D
photographs. The Breast Analyzing Tool (BAT©) evaluates symmetry by comparing breast area,
breast circumference and nipple position between the breasts. The Breast Cancer Conservative
Treatment cosmetic result (BCCT.core) also analyses colour differences and the scar
appearance in addition to asymmetry calculations.
The use of 3D surface imaging in the clinical setting was first described by Burke and Beard
in 1967 to analyze facial structures. Over the last fifteen years 3D imaging has been used as
a research and clinical tool in aesthetic, oncoplastic and reconstructive breast surgery.
Initial studies established optimal technique to obtain images and tested accuracy and
reproducibility. 3D imaging is currently used to simulate for the patient what a cosmetic
augmentation might achieve in terms of size and shape. It has been demonstrated that
simulated images are accurate and patients felt they helped them to choose the implant.
In terms of oncoplastic reconstructive surgery 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). Moyer et al analyzed twenty three patients who had undergone
BCT and compared volume and asymmetry. They found that there was a positive correlation
between percentage of breast parenchyma excised and asymmetry. The location of the cancer,
age of the patient and need for multiple operations did not influence cosmetic results but
the sample size was small and therefore likely underpowered.
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.
