An interventional study of Additional MRI with gadolinium injection and 3D camera imaging in Subclinical Breast Cancer Lesion, sponsored by Centre Jean Perrin. Recruiting at 1 site in France. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Centre Jean Perrin · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Feasibility of the study
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.
Time frame: 1 year
Time measurement of the study procedure
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.
Time frame: 1 year
Creating a phantom
Success of creating a phantom is deemed to have been achieved if the breast Phantom including all clinical features
Time frame: 1 year
Assessment of the feasibility of images fusion
Assessment of the feasibility of fusing supine 3D breast MRI images and post-MRI ultrasound (second look) with target lesion detection.
Time frame: 1 year
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