Clinical trial · Observational
PICTURE Breast L: Patient Information Combined for Local Therapy oUtcome Assessment in bREast Cancer - Longitudinal
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Creation of a reliable demonstrator.
- timeFrame
- One year
- description
- 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.
Secondary outcomes (1)
- measure
- Assess health-related quality of life.
- timeFrame
- One year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women undergoing breast conserving surgery for early breast cancer. * Willing and able to return for a one-year visit. * Written informed consent obtained. Exclusion Criteria: * 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.).
References
Publications (0)
Data not yet available