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Breast NeoplasmsPICTURE LNCT02341820

PICTURE Breast L: Patient Information Combined for Local Therapy oUtcome Assessment in bREast Cancer - Longitudinal

An observational study of Breast Neoplasms, run by University College, London at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project which is fully funded by the European Union FP7 Program is designed to pull together all the information we obtain from scans and x-rays to design a personalised 3-D digital model of each patient, their anatomy and disease. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
How many people
83 participants
Where
3 sitesin 3 countries
Study dates
Apr 2014to Dec 2016
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Women who are scheduled to undergo breast conserving surgery for early breast cancer.

Who may be able to join

  • Women undergoing breast conserving surgery for early breast cancer.
  • Willing and able to return for a one-year visit.
  • Written informed consent obtained.

Who cannot join

  • Unable to provide written informed consent.
  • Younger than 18 years.
  • Benign breast disease.
  • Women undergoing mastectomy.
  • Unable to have an MRI scan (e.g. claustrophobia, too large, etc.).

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Netherlands1 site
  • Leiden University Medical Center (LUMC)

    Leiden

Other trials in Netherlands

Portugal1 site
  • Champalimaud Cancer Center

    Lisbon

Other trials in Portugal

United Kingdom1 site
  • Royal Free Hospital

    London, NW3 2QG

Other trials in United Kingdom

About this study

This project which is fully funded by the European Union FP7 Program is designed to pull together all the information we obtain from scans and x-rays to design a personalised 3-D digital model of each patient, their anatomy and disease. We can then use this as follows: as (i) an aid to surgical planning to enable objective clinical decision making (ii) a decision support tool to communicate the available treatment options to the patient and facilitate shared decision making and provision of personalised care and (iii) to enable standardised objective evaluation of the aesthetic outcome of the treatment procedures. This study aims to demonstrate the ability of the Virtual Physiological Human concept to empower breast cancer patients and assess the impact on their care and quality of life.

Read the detailed description

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 and to enable standardised evaluation and a safe outcome of the procedure. The demonstrator aims to empower patients and will have a direct impact on their care and quality of life.

Keywords
breast cancer, breast conserving surgery, cosmesis
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Creation of a reliable demonstrator.

    The primary objective of the study is to create a reliable demonstrator (software) by integrating models of surgical techniques and treatment schemes, clinical patient data, multi-modal imaging and individualised models of patient anatomy. The demonstrator will be used as an aid to objective 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 and to enable standardised evaluation of the procedure.

    Measured: One year

Secondary outcomes (1)
  1. Assess health-related quality of life.

    The secondary objective is to assess the health-related quality of life at baseline (before surgery) and one year after surgery, in the women who are participating in this study. Together with characteristics of the patient and the breast tumour, these data will describe the patient group on whom the demonstrator is constructed, which will be used to inform the design and size of a subsequent evaluation study.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionFeb 2016
  4. Study completionDec 2016

Resources

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
Prospective
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02341820
Sponsor's protocol ID
8713
Acronym
PICTURE L
Status last verified
Oct 2016
First submitted
13 Jan 2015
Last updated
17 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: All requests for data sharing will adhere to the UCL Surgical \& Interventional Trials Unit (SITU) data sharing agreement policy. UCL Medical School is supportive of data sharing and will endeavour to assist in requests for data sharing. These data will be held at UCL on secure servers and will not be released to any third parties until the final study report has been published. All requests for access to the data will be formally requested through the use of a SITU data request form which will state the purpose, analysis and publication plans together with the named collaborators. All requests are dealt with on a case by case basis. All requests will be logged and those successful will have a data transfer agreement which will specify appropriate acknowledgement of the Royal Free Hospital, the sponsor, and funders.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms, run by University College, London at 3 sites in 3 countries.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands, Portugal, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Creation of a reliable demonstrator. (time frame: One year). 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 17 Mar 2017.

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