Augmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery (AR-GBS)

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.

Study Overview

• Status: Recruiting
• Conditions: Subclinical Breast Cancer Lesion
• Intervention / Treatment: Procedure: Additional MRI with gadolinium injection and 3D camera imaging

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Céleste PINARD; Phone Number: 0473278005; Email: Celeste.PINARD@clermont.unicancer.fr
• Study Contact Backup: Name: Dr Sabrina MADAD-ZADEH; Phone Number: 0473278005

Study Locations

• France
  • Clermont-Ferrand, France, 63011
    • Recruiting
    • Centre Jean Perrin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
Creating a phantom	Success of creating a phantom is deemed to have been achieved if the breast Phantom including all clinical features	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.	1 year

Collaborators and Investigators

• Sponsor: Centre Jean Perrin

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Inorganic Chemicals; Elements; Metals; Lanthanoid Series Elements; Metals, Rare Earth; Gadolinium
• Other Study ID Numbers: 2023-A02648-37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No