Augmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery
- Conditions
- Subclinical Breast Cancer Lesion
- Interventions
- Procedure: Additional MRI with gadolinium injection and 3D camera imaging
- Registration Number
- NCT06512558
- Lead Sponsor
- Centre Jean Perrin
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 10
- 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
- Patients with breast neoplasia during pregnancy;
- Persons deprived of their liberty or under guardianship or incapable of giving consent;
- Refusal to participate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Interventional Additional MRI with gadolinium injection and 3D camera imaging -
- Primary Outcome Measures
Name Time Method Feasibility of the study 1 year 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 Outcome Measures
Name Time Method Time measurement of the study procedure 1 year Measurement of the time required to complete the various stages of the study procedure and surgery : device set-up, marking of registration marks on the patient's bust with a dermographic pencil, 3D acquisition of the patient's bust using a 3D camera, duration of the procedure, anesthesia time.
Creating a phantom 1 year Success of creating a phantom is deemed to have been achieved if the breast Phantom including all clinical features
Assessment of the feasibility of images fusion 1 year Assessment of the feasibility of fusing supine 3D breast MRI images and post-MRI ultrasound (second look) with target lesion detection.
Trial Locations
- Locations (1)
Centre Jean PERRIN
🇫🇷Clermont-Ferrand, France