Dataset Information

Wire- and magnetic-seed-guided localization of impalpable breast lesions: iBRA-NET localisation study.

ABSTRACT:

Background

Wire localization is historically the most common method for guiding excision of non-palpable breast lesions, but there are limitations to the technique. Newer technologies such as magnetic seeds may allow some of these challenges to be overcome. The aim was to compare safety and effectiveness of wire and magnetic seed localization techniques.

Methods

Women undergoing standard wire or magnetic seed localization for non-palpable lesions between August 2018 and August 2020 were recruited prospectively to this IDEAL stage 2a/2b platform cohort study. The primary outcome was effectiveness defined as accurate localization and removal of the index lesion. Secondary endpoints included safety, specimen weight and reoperation rate for positive margins.

Results

Data were accrued from 2300 patients in 35 units; 2116 having unifocal, unilateral breast lesion localization. Identification of the index lesion in magnetic-seed-guided (946 patients) and wire-guided excisions (1170 patients) was 99.8 versus 99.1 per cent (P = 0.048). There was no difference in overall complication rate. For a subset of patients having a single lumpectomy only for lesions less than 50 mm (1746 patients), there was no difference in median closest margin (2 mm versus 2 mm, P = 0.342), re-excision rate (12 versus 13 per cent, P = 0.574) and specimen weight in relation to lesion size (0.15 g/mm2versus 0.138 g/mm2, P = 0.453).

Conclusion

Magnetic seed localization demonstrated similar safety and effectiveness to those of wire localization. This study has established a robust platform for the comparative evaluation of new localization devices.

SUBMITTER: Dave RV

PROVIDER: S-EPMC10364683 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Publications

Wire- and magnetic-seed-guided localization of impalpable breast lesions: iBRA-NET localisation study.

Dave Rajiv V RV Barrett Emma E Morgan Jenna J Chandarana Mihir M Elgammal Suzanne S Barnes Nicola N Sami Amtul A Masudi Tahir T Down Sue S Holcombe Chris C Potter Shelley S Somasundaram Santosh K SK Gardiner Matthew M Mylvaganam Senthurun S Maxwell Anthony A Harvey James J

The British journal of surgery 20220201 3

<h4>Background</h4>Wire localization is historically the most common method for guiding excision of non-palpable breast lesions, but there are limitations to the technique. Newer technologies such as magnetic seeds may allow some of these challenges to be overcome. The aim was to compare safety and effectiveness of wire and magnetic seed localization techniques.<h4>Methods</h4>Women undergoing standard wire or magnetic seed localization for non-palpable lesions between August 2018 and August 202 ...[more]

PMID: 35089321

Similar Datasets

Project description:ObjectiveThe objective of this retrospective study was to investigate the accuracy and feasibility of magnetic seed compared to skin tattoo in preoperative localization of impalpable breast lesions in terms of accuracy of placement, re-excision and positive margins rates, and breast/surgical specimen volume ratio.MethodsWe retrospectively analyzed 77 patients who underwent breast conservative surgery in our center from November 2020 to November 2021, with previous localization with skin tattoo or magnetic seed.ResultsThirty-seven magnetic seeds were placed in 36 patients (48.6%) and 40 skin tattoos were performed in the remaining cases (51.4%). The seeds were placed correctly at the two-view mammogram acquired after the insertion in 97.6% (36/37) of cases. With both methods, 100% of the index lesions were completely removed and found in the surgical specimen. The reported re-excision rate was 0% for both groups. A significant difference was observed in the volume of breast parenchyma removed between the two groups, inferior in the seed group (p = 0.046), especially in case of voluminous breasts (p = 0.003) and small lesions (dimension < 8 mm, p = 0.019).ConclusionsMagnetic seed is a non-radioactive localization technique, feasible to place, recommended in case of non-palpable breast lesions, saving the breast parenchyma removed compared with skin tattoo, without reducing the accuracy.Clinical relevance statementOur findings contribute to the current evidence on preoperative localization techniques for non-palpable breast lesions, highlighting the efficacy of magnetic seed localization for deep and small lesions.Key points• Magnetic seed is a non-radioactive technique for the preoperative localization of non-palpable breast lesions studied in comparison with skin tattoo. • Magnetic seed is feasible to place in terms of post-placement migration and distance from the target lesion. • Magnetic seed is recommended in case of non-palpable breast lesions, saving the breast parenchyma removed without reducing the accuracy.

Project description:BackgroundBreast cancer is the most frequently diagnosed cancer and the leading cause of cancer death in women. Approximately 50% of breast cancers are discovered at an early stage in patients for whom conservative surgery is indicated. Intraoperative localization of non-palpable breast lesions is generally accomplished using a hook wire to mark the area of concern under ultrasound or stereotactic localization. But this technique has several drawbacks (painful, stressful…). We propose the use of a wire-free breast lesion system using miniature radiofrequency identification (RFID) tags. This technique could improve patient comfort and surgical comfort for surgeons. We therefore propose a study to assess the interest of introducing the RFID localization technique at the Jean PERRIN comprehensive cancer center.MethodsThis is a single-center prospective trial designed to assess the interest in introducing the RFID localization technique at the Jean Perrin center. It aims to show the superiority of the RFID technique in terms of patient tolerance compared to the gold-standard (hook wire). A sequential inclusion in time will be performed: 20 inclusions in the gold-standard group, then 20 patients in the RFID group before repeating the inclusion scheme. Any patient requiring preoperative localization will receive a senology consultation. The RFID tag will be placed during this consultation. The hook wire localization will be done the day before the surgery. Patients will fill out a Hospital Anxiety and Depression scale (HAD) questionnaire at the time of inclusion. They will then fill out a satisfaction questionnaire in 2 steps: during the placement of the device (RFID tag or hook wire) or during the postoperative consultation at 1 month. Radiologists and surgeons will fill out a questionnaire to evaluate the localization technique, respectively after the localization and surgery procedures.DiscussionThe RFID study is the first study in France which specifically assesses the interest of the RFID localization in terms of patients comfort. Patient comfort is one of the key elements to take into consideration when managing patients in oncology and new technologies such as RFID tags could improve it.Trial registrationClinicalTrials.gov ID; NCT04750889 registered on February 11, 2021.

Project description:BackgroundMost breast cancers are detected at an early stage in which case conservative surgery is indicated. An accurate preoperative localization technique is essential for conservative surgery of non-palpable breast lesions. Currently, the gold standard technique is wire localization (WL). However, this technique has well-known drawbacks. Several wire-free techniques have been developed to overcome these drawbacks; one technique is localisation by Radiofrequency Identification (RFID). The purpose of this clinical trial was to assess the superiority of RFID tags (HOLOGIC) in terms of patient satisfaction, over wire localization of non-palpable breast lesions.MethodsThis was a single-centre, prospective, controlled and non-interventional trial. Patients were followed from their inclusion at the time of the preoperative consultation to the postoperative consultation, one month after surgery. Data on anxiety and satisfaction was collected from patients and clinicians using questionnaires, and clinical data was collected from the medical files. The primary outcome was the patients' satisfaction scores, assessed using a visual analogue scale.ResultsEighty patients were sequentially enrolled in two groups: the wire group (n = 40) and the RFID group (n = 40). One patient from the RFID group was excluded from the analysis because of a substantial migration during deployment. On a 10-point Visual Analogue Scale, the patients' median satisfaction score was 9.8 (IQR = 1.32) for the wire group and 10 (IQR = 0.07) for the RFID group (p < 0.001). A reduction in pain between device insertion and surgery was observed in the RFID group (p = 0.009). The median placement time was shorter in the RFID group (15 min, IQR = 6) than in the wire group (20 min, IQR = 30) (p = 0.01).ConclusionOur results show a statistically significant difference in median patient satisfaction score with the localization of non-palpable breast cancer lesions using RFID tags compared to the use of the WL. Although our results did not show clinically significant outcomes in terms of satisfaction, RFID tags are a reliable alternative to WL and simplify the organization of patients' healthcare trajectories.Trial registrationClinicalTrials.gov ID; NCT04750889 registered on February 11, 2021. https://clinicaltrials.gov/ct2/show/NCT04750889?term=rfid&draw=2&rank=1.

Project description:BackgroundPreoperative computed tomography (CT)-guided localization of small pulmonary nodules (SPNs) is the major approach for accurate intraoperative visualization in video-assisted thoracoscopic surgery (VATS). However, this interventional procedure has certain risks and may challenge to less experienced junior doctors. This study aims to evaluate the feasibility and efficacy of robotic-assisted CT-guided preoperative pulmonary nodules localization with the modified hook-wire needles before VATS.MethodsA total of 599 patients with 654 SPNs who preoperatively accepted robotic-assisted CT-guided percutaneous pulmonary localization were respectively enrolled and compared to 90 patients with 94 SPNs who underwent the conventional CT-guided manual localization. The clinical and imaging data including patients' basic information, pulmonary nodule features, location procedure findings, and operation time were analyzed.ResultsThe localization success rate was 96.64% (632/654). The mean time required for marking was 22.85±10.27 min. Anchor of dislodgement occurred in 2 cases (0.31%). Localization-related complications included pneumothorax in 163 cases (27.21%), parenchymal hemorrhage in 222 cases (33.94%), pleural reaction in 3 cases (0.50%), and intercostal vascular hemorrhage in 5 cases (0.83%). Localization and VATS were performed within 24 hours. All devices were successfully retrieved in VATS. Histopathological examination revealed 166 (25.38%) benign nodules and 488 (74.62%) malignant nodules. For patients who received localizations, VATS spent a significantly shorter time, especially the segmentectomy group (93.61±35.72 vs. 167.50±40.70 min, P<0.001). The proportion of pneumothorax in the robotic-assisted group significantly decreased compared with the conventional manual group (27.21% vs. 43.33%, P=0.002).ConclusionsRobotic-assisted CT-guided percutaneous pulmonary nodules hook-wire localization could be effectively helpful for junior less experienced interventional physicians to master the procedure and potentially increase precision.

Dataset Information

Wire- and magnetic-seed-guided localization of impalpable breast lesions: iBRA-NET localisation study.

Background

Methods

Results

Conclusion

Publications

Wire- and magnetic-seed-guided localization of impalpable breast lesions: iBRA-NET localisation study.

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