Clinical trial · Interventional
Augmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery
- 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)
Breast cancer is diagnosed by imaging at a non-palpable stage in more than half of all cases. Surgical removal requires preoperative guidance. Generally, preoperative guidance is performed using a metal guide under local anaesthetic and radiological control. This type of guidance has several limitations. For the patient, it can be painful and traumatic. The procedure involves two departments: radiology and the operating theatre, which poses logistical constraints. What's more, between 10% and 40% of patients require repeat surgery for unhealthy margins, raising the question of the effectiveness of the tracking procedure. The investigators propose to develop a non-invasive intraoperative guidance system: Augmented Reality, which will provide a 3D vision with virtual transparency of the breast during surgery, thanks to real-time fusion of preoperative imaging with video from a camera located in the operating room. The process is illustrated below. Illustration of the general principle of the augmented reality system for locating non-palpable breast lesions. The images above represent a preliminary test carried out on the computer outside the operating room. This is an initial research prototype which has not yet been validated and is not suitable for routine use.
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 |
|---|---|---|---|
| Subclinical Breast Cancer Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additional MRI with gadolinium injection and 3D camera imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interventional
- interventionNames
- Procedure: Additional MRI with gadolinium injection and 3D camera imaging
Primary outcomes (1)
- measure
- Feasibility of the study
- timeFrame
- 1 year
- description
- The feasibility of the study will be considered to have been achieved if the investigators obtain at least 4 successes among the 5 patients who benefited from the augmented reality procedure pre- and intraoperatively. Success is defined at both preoperative and intraoperative levels. Success in the preoperative phase is defined by: visibility of registration landmarks (clavicle, sternal fork, sternum, xyphoid process and areolar-nipple plate). Success in the intraoperative phase is defined by: non-prolongation of anesthesia time due to the study procedure.
Secondary outcomes (3)
- measure
- Time measurement of the study procedure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Major women * Requiring conservative surgical management of a subclinical cancerous breast lesion (not palpable), the histology of which has been previously proven by anatomopathology; * Having a breast MRI indication at the time of the breast assessment performed at the Centre Jean Perrin * Ability to give informed consent to participate in the study, * Membership of a social security scheme Exclusion Criteria: * Patients with breast neoplasia during pregnancy; * Persons deprived of their liberty or under guardianship or incapable of giving consent; * Refusal to participate.
References
Publications (0)
Data not yet available