Clinical trial · Observational
Pilot Study for 3-Dimensional Surface Imaging in Implant-based Breast Reconstruction
Pilot Study Towards Development of an Objective Evaluation of Outcome After Implant-based Breast Reconstruction, Using 3D-surface Imaging (3D-SI) and the Feasibility of a Novel Online Research Tool.
- 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)
Measuring appearance of implant-based breast reconstruction after mastectomy for breast cancer - an online approach to research. Using 3-dimensional surface images we intend to create a tool to measure appearance after surgery in order to improve standards of care for women. We want to minimise the number of visits and amount of time involved in research participation so this pilot study will develop new online tools for information giving and gathering, and for consent so that only one visit to hospital will be required for photographs. This will also extend the availability of expensive 3D technology to more women.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional Surface Image | Other | — | UNRESOLVED |
| Reconstruction BREAST-Q | Other | — | UNRESOLVED |
| Treatment Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Recruitment Rate to a study of this design
- timeFrame
- 3 months
- description
- The study team will assess the number of participants as a proportion of those approached. The study team will assess the proportion of those approached versus those who complete the recruitment process by attending for their 3D-SI.
Secondary outcomes (7)
- measure
- To understand dropout rates
- timeFrame
- 6 months
- description
- Dropout rate - participants who complete the online recruitment process as a proportion of the number who start the process i.e. those who consent to the study versus those who progress through to booking their photography slot. The user survey is not a compulsory part of the study, therefore if it is not filled it will not preclude women from completing the study by having a 3D-SI.
- measure
- To understand how long it takes to complete the online recruitment process.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients * Over 18 years * Have undergone implant-based reconstruction 1-5 years before study entry (can be unilateral or bilateral, immediate or delayed, nipple-sparing or nipple-sacrificing, risk reducing or therapeutic) Exclusion Criteria: * \<1 year or over 5 years from surgery * Explantation * Local or distant recurrence * Lacks capacity
References
Publications (3)
- BACKGROUNDPusic et al. Measuring Quality of Life in Breast Surgery: Content development of a new modular system to capture patient reported outcomes (The MSKCC BREAST-Q). ISOQOL Annual Meeting. October 2006 Lisbon, Portugal
- RESULTPusic AL, Chen CM, Cano S, Klassen A, McCarthy C, Collins ED, Cordeiro PG. Measuring quality of life in cosmetic and reconstructive breast surgery: a systematic review of patient-reported outcomes instruments. Plast Reconstr Surg. 2007 Sep 15;120(4):823-837. doi: 10.1097/01.prs.0000278162.82906.81. PMID 17805107
- DERIVEDGodden AR, Wood SH, James SE, MacNeill FA, Rusby JE. A scoring system for 3D surface images of breast reconstruction developed using the Delphi consensus process. Eur J Surg Oncol. 2020 Sep;46(9):1580-1587. doi: 10.1016/j.ejso.2020.05.016. Epub 2020 Jun 7. PMID 32620404