NCT06512558

Augmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Centre Jean Perrin · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

• Subclinical Breast Cancer Lesion

Interventions

Type	Name	Description
PROCEDURE	Additional MRI with gadolinium injection and 3D camera imaging	The study includes an additional MRI with gadolinium injection, performed in addition to standard practice. In addition, 3D camera images will be acquired at the time of surgery.

Timeline

• Start date: 2024-11-14
• Primary completion: 2027-11-01
• Completion: 2027-12-01
• First posted: 2024-07-22
• Last updated: 2025-12-31

Locations

1 site across 1 country: France