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

NCT06512558 | Recruiting

• 1 other identifier: 2023-A02648-37
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Subclinical Breast Cancer Lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time measurement of the study procedure

  1 year

• Creating a phantom

  1 year

• Assessment of the feasibility of images fusion

  1 year

Study Arms (1)

Interventional

EXPERIMENTAL

Procedure: Additional MRI with gadolinium injection and 3D camera imaging

Interventions

Additional MRI with gadolinium injection and 3D camera imaging PROCEDURE

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.

Interventional

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with breast neoplasia during pregnancy;
• Persons deprived of their liberty or under guardianship or incapable of giving consent;
• Refusal to participate.

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (1)

Centre Jean PERRIN

Clermont-Ferrand, 63011, France

RECRUITING

MeSH Terms

Interventions

Gadolinium

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Central Study Contacts

Céleste PINARD

CONTACT

0473278005; Celeste.PINARD@clermont.unicancer.fr

Dr Sabrina MADAD-ZADEH

CONTACT

0473278005

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 22, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

FR (1)