An interventional study of Additional MRI with gadolinium injection and 3D camera imaging in Subclinical Breast Cancer Lesion, sponsored by Centre Jean Perrin. Recruiting at 1 site in France. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Centre Jean Perrin · Not applicable, Interventional, and Treatment
Among 24 studies in Breast Neoplasms by Centre Jean Perrin — 2 open to participants now, 3 under way, none of them phase 3. Breast Neoplasms · Centre Jean Perrin.
Among the 24 studies in Breast Neoplasms by Centre Jean Perrin, this one is the 16th largest by planned enrollment of the 21 interventional ones that give a count, is the only one that started in 2024, is one of 13 with no phase, and was the 24th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →2 of the 24 studies in Breast Neoplasms by Centre Jean Perrin are open now, in 1 country. Recruiting first, the newest first:
Centre Jean Perrin · Sites in France
By country, each count listing its studies:
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years to 100 Years · female · no healthy volunteers.
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24 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2024.
This study's planned enrollment of 20 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 36 across the 21 interventional studies, 240 across the 3 observational. Of the 20 that completed or were terminated, 0 (0%) have results posted.
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Centre Jean Perrin is the lead sponsor of 55 studies on the registry; 8 are open to participants now.
1 of the studies in Breast Neoplasms by Centre Jean Perrin that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06512558Centre Jean PerrinAugmented Reality Feasibility for Non-invasive Preoperative Tracking in Breast Cancer Surgery | 2027-11-01 |
Among the 24 studies in Breast Neoplasms by Centre Jean Perrin, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 1 year
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.
Time frame: 1 year
Creating a phantom
Success of creating a phantom is deemed to have been achieved if the breast Phantom including all clinical features
Time frame: 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.
Time frame: 1 year
Started Nov 2024 (actual). Primary completion is estimated for Nov 2027, 35 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 35 months is close to that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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Centre Jean Perrin