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NCT Number: NCT06512558

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

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Jean PERRIN

Clermont-Ferrand, 63011, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of the study

    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.

Secondary outcomes

  1. Time measurement of 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.

  2. Creating a phantom

    Time frame: 1 year

    Success of creating a phantom is deemed to have been achieved if the breast Phantom including all clinical features

  3. Assessment of the feasibility of images fusion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Céleste PINARD

CONTACT

[email protected]

0473278005

Dr Sabrina MADAD-ZADEH

CONTACT

0473278005

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Acronym: AR-GBS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2024
Registry last updated
Dec 31, 2025

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.