Breast Cancer3DBCTNCT02304614
The Use of 3D Surface Imaging in the Objective Assessment of Breast Conserving Therapy
An observational study of Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 3D surface imaging using a non portable and portable camera, Patient reported outcome measure (PROM): BREAST-Q and 2D photography
- How many people
- 346 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2015to 24 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who have undergone Breast Conserving Therapy at least one year ago
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
About this study
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.
Read the detailed 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.
- Conditions
- Breast Cancer
- Being tested
- 3D surface imaging using a non portable and portable camera, Patient reported outcome measure (PROM): BREAST-Q, 2D photography, Applanation Tonometry
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D surface imaging using a non portable and portable cameraOther
Also called 3D photography
The participant will have 3D surface imaging taken of their breasts (the face will not be shown)
Patient reported outcome measure (PROM): BREAST-QOther
The participant will answer the BREAST-Q questionnaire. This is a patient reported outcome measurement of satisfaction and quality of life after BCT
2D photographyOther
Also called medical photography
The participant will have standard medical photography of their breasts (the face will not be shown)
Applanation TonometryOther
Also called Measurement of breast compressibility
A small 300g disc is placed on the breast to measure the surface area of contact with the breast to measure compressibility
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients who have undergone Breast conserving Therapy Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
A multivariate model using clinical risk factors to predict percentage volume asymmetry
Measured: 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: measured on day of imaging
Establishment of the most reproducible method to measure focal deficits using 3D surface imaging
Measured: 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: measured on day of imaging
Comparison of compressibility of treated and untreated breasts as measured by applanation tonometry
Measured: measured on day of imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study start1 Apr 2015
- Primary completion22 Mar 2017
- Study completion24 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer E Rusby, DM FRCS, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304614
- Sponsor's protocol ID
- CCR4252
- Acronym
- 3DBCT
- Status last verified
- Oct 2020
- First submitted
- 27 Nov 2014
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of 3D Surface Imaging in the Objective Assessment of Breast Conserving Therapy
- ClinicalTrials.gov ID
- NCT02304614
- Acronym / sponsor ID
- 3DBCT / CCR4252
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 22 Mar 2017 (actual)
- Study completion
- 24 Dec 2020 (estimated)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: 3D surface imaging using a non portable and portable camera, Other: Patient reported outcome measure (PROM): BREAST-Q, Other: 2D photography, Other: Applanation TonometryPatients who have undergone Breast conserving Therapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have undergone Breast Conserving Therapy at least one year ago
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D surface imaging using a non portable and portable cameraAlso: 3D photographyThe participant will have 3D surface imaging taken of their breasts (the face will not be shown) | Other | Group 1 |
| Patient reported outcome measure (PROM): BREAST-QThe participant will answer the BREAST-Q questionnaire. This is a patient reported outcome measurement of satisfaction and quality of life after BCT | Other | Group 1 |
| 2D photographyAlso: medical photographyThe participant will have standard medical photography of their breasts (the face will not be shown) | Other | Group 1 |
| Applanation TonometryAlso: Measurement of breast compressibilityA small 300g disc is placed on the breast to measure the surface area of contact with the breast to measure compressibility | Other | Group 1 |
Primary outcome
A multivariate model using clinical risk factors to predict percentage volume asymmetry
Time frame: measured on day of imaging
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer E Rusby, DM FRCS principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A multivariate model using clinical risk factors to predict percentage volume asymmetry (time frame: measured on day of imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.