NCT06512558 Augmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery
| NCT ID | NCT06512558 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Jean Perrin |
| Condition | Subclinical Breast Cancer Lesion |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-11-14 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-11-14 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06512558 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Subclinical Breast Cancer Lesion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06512558 currently recruiting?
Yes, NCT06512558 is actively recruiting participants. Contact the research team at Celeste.PINARD@clermont.unicancer.fr for enrollment information.
Where is the NCT06512558 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT06512558 clinical trial?
NCT06512558 is sponsored by Centre Jean Perrin. The trial plans to enroll 20 participants.
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