Centre Jean PERRIN
Clermont-Ferrand, 63011, France
Location status: Recruiting
NCT Number: NCT06512558
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.
Interested in participating?
Request Info18 year–100 year
Female
Interventional
Not applicable
Clermont-Ferrand, 63011, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
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 fusing supine 3D breast MRI images and post-MRI ultrasound (second look) with target lesion detection.
Contact information is provided by the study sponsor or research team.
Centre Jean Perrin
Other
Acronym: AR-GBS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.