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

NCT ID: NCT06512558

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-14

Study Completion Date

2027-12-01

Brief Summary

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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

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Conditions

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Subclinical Breast Cancer Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional

Group Type EXPERIMENTAL

Additional MRI with gadolinium injection and 3D camera imaging

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Jean Perrin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Jean PERRIN

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Céleste PINARD

Role: CONTACT

Phone: 0473278005

Email: [email protected]

Dr Sabrina MADAD-ZADEH

Role: CONTACT

Phone: 0473278005

Other Identifiers

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2023-A02648-37

Identifier Type: -

Identifier Source: org_study_id