Patient information combined for local therapy outcome assessment in bresast cancer.

Breast cancer is the most common cancer to affect women in Europe, having a
lifetime risk of 1 in 9. It is an increasingly treatable disease, and 10-year
survival now exceeds 80%. The primary treatment for breast cancer is surgery,
which may be used in conjunction with adjuvant therapies, such as chemotherapy
and radiotherapy. Given the high breast cancer survival rate, many women will
live for many years with the potentially disfiguring aesthetic consequences of
their surgical and therapeutic treatment. A good aesthetic outcome is an
important endpoint for breast cancer treatment and is closely related to
psychosocial recovery and quality of life.
When a woman faces a breast cancer diagnosis, and surgery is proposed, several
options are available. The decision as to which type of surgery to offer
patients is largely subjective and based almost exclusively on the judgment and
experience of the clinician. The cosmetic outcome of surgery is a function of
many factors including tumour size and location, the volume of the breast, its
density, and the dose and distribution of radiotherapy. In breast-conserving
surgery, there is evidence that approximately 30% of women receive a suboptimal
or poor aesthetic outcome; however there is currently no standardised method of
identifying these women.

The PICTURE project aims to address these issues by providing objective tools,
tailored to the individual patient, to predict the aesthetic outcome of local
treatment. Using a combination of 3D photography and routinely acquired
radiological images (i.e. mammography, ultrasound and MRI, when available),
together with information about the tumour (size, location, shape etc.) we will
develop techniques to biomechanically model the anatomy of the breast and the
effect of surgical removal of cancerous tissue. This digital patient
representation and associated predictive tools will enable alternative surgical
strategies to be explored and the consequences of the available options, with
respect to the appearance of the breast, to be visualised. This will aid
communication with the patient of the type of breast surgery recommended by the
surgeon, and will empower patients to take an active role in a shared decision
making process.
The study will develop tools to enable the patient*s aesthetic appearance after
treatment to be objectively evaluated. Current techniques use subjective
methods, such as assessment by an expert panel, or computer analysis of
2-dimensional photography to estimate, for instance, breast asymmetry. By
adopting recent developments in low cost 3D photography and depth sensing
technology, we will develop a standardised, reproducible analysis tool which
will base the aesthetic outcome evaluation on both the 3-dimensional shape of
the reconstructed breast and its volume. This will establish standardised
quality assurance and evaluation procedures, enabling institutions across
Europe to be compared and factors that have a positive or negative impact on
surgical outcome identified.
In summary, the demonstrator created by the PICTURE project will integrate
models of surgical techniques and treatment schemes, clinical patient data,
multi-modal imaging and individualised models of patient anatomy to build a
personalised, digital representation of the patient. The aim is for this to be
used as an aid to surgical planning, via simulation of the cosmetic effects of
breast conserving surgery, as a decision support tool to communicate the
available options to the patient.

This is a cross-sectional study with no clinical interventions.

After providing written informed consent, each patient will be asked to:
1) Have her height, weight, bra and cup size recorded by a member of the
clinical team.
2) Complete three questionnaires.
3) Have photographs taken of her unclothed torso (neck to navel) from various
angles using several cameras, including a 3D camera.

This will complete the patient*s participation in the study.

After consent, each study patient will have photographs of her unclothed torso
taken (from neck to navel) at various angles according to a pre-specified
protocol. Height, weight and bra size will also be recorded at this time. In
addition, the study patient will be asked to complete questionnaires. The
estimated time taken for consent, photography and questionnaire completion is
between two and three hours per subject.

We do not forsee any major risks or burdens for patients arising from this
study.

However, some women may feel anxious when completing the questionnaires. A
trained member of the study team will be available if the women wish to discuss
any matters which concern them.

In addition, some women may feel uncomfortable having photographs taken of
their breasts one year after surgery. This will be made clear to them during
the consent process; and they will be free to withdraw from the study at any
time, even in the photography studio.