Dataset Information

Enhanced pre-operative axillary staging using intradermal microbubbles and contrast-enhanced ultrasound to detect and biopsy sentinel lymph nodes in breast cancer: a potential replacement for axillary surgery.

ABSTRACT: OBJECTIVE:To compare the experience of four UK Centres in the use of intradermal microbubbles and contrast enhanced ultrasound (CEUS) to pre-operatively identify and biopsy sentinel lymph nodes (SLN) in patients with breast cancer. METHODS:In all centres, breast cancer patients had a microbubble/CEUS SLN core biopsy prior to axillary surgery and patients in Centres 1 and 2 had a normal greyscale axillary ultrasound. Data were collected between 2010 and 2016; 1361 from Centre 1 (prospective, sequential), 376 from Centre 2 (retrospective, sequential), 121 from Centre 3 (retrospective, selected) and 48 from Centre 4 (prospective, selected). RESULTS:SLN were successfully core biopsied in 80% (Centre 1), 79.6% (Centre 2), 77.5% (Centre 3) and 88% (Centre 4). The sensitivities to identify all SLN metastases were 46.9% [95% confidence intervals (CI) (39.4-55.1)], 52.5% [95% CI (39.1-65.7)], 46.4% [95% CI (27.5-66.1)] and 45.5% [95% CI (16.7-76.6)], respectively. The specificities were 99.7% [95% CI (I98.9-100)], 98.1% [95% CI (94.5-99.6)], 100% [95% CI (93.2-100%)] and 96.3% [95% CI (81-99.9)], respectively.The negative predictive values were 87.0% [95% CI (84.3-89.3)], 84.5% [95% CI (78.4-89.5)], 86.9% [95% CI (82.4-90.3)] and 86.2% [95% CI (78.4-91.5)], respectively. At Centres 1 and 2, 12/730 (1.6%) and 7/181 (4%), respectively, of patients with a benign microbubble/CEUS SLN core biopsy had two or more lymph node (LN) macrometastases found at the end of primary surgical treatment. CONCLUSION:The identification and biopsy of SLN using CEUS is a reproducible technique. Advances in knowledge: In the era of axillary conservation, microbubble/CEUS SLN core biopsy has the potential to succeed surgical staging of the axilla.

SUBMITTER: Cox K

PROVIDER: S-EPMC5965773 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Enhanced pre-operative axillary staging using intradermal microbubbles and contrast-enhanced ultrasound to detect and biopsy sentinel lymph nodes in breast cancer: a potential replacement for axillary surgery.

Cox Karina K Taylor-Phillips Sian S Sharma Nisha N Weeks Jennifer J Mills Philippa P Sever Ali A Lim Adrian A Haigh Isobel I Hashem Mohamed M de Silva Tania T Satchithananda Keshthra K Tang Mengxing M Wallis Matthew M

The British journal of radiology 20171205 1082

<h4>Objective</h4>To compare the experience of four UK Centres in the use of intradermal microbubbles and contrast enhanced ultrasound (CEUS) to pre-operatively identify and biopsy sentinel lymph nodes (SLN) in patients with breast cancer.<h4>Methods</h4>In all centres, breast cancer patients had a microbubble/CEUS SLN core biopsy prior to axillary surgery and patients in Centres 1 and 2 had a normal greyscale axillary ultrasound. Data were collected between 2010 and 2016; 1361 from Centre 1 (pr ...[more]

PMID: 29125333

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Project description:ImportanceSentinel lymph node biopsy (SLNB) is the standard of care for axillary node staging of patients with early breast cancer (BC), but its necessity can be questioned since surgery for examination of axillary nodes is not performed with curative intent.ObjectiveTo determine whether the omission of axillary surgery is noninferior to SLNB in patients with small BC and a negative result on preoperative axillary lymph node ultrasonography.Design, setting, and participantsThe SOUND (Sentinel Node vs Observation After Axillary Ultra-Sound) trial was a prospective noninferiority phase 3 randomized clinical trial conducted in Italy, Switzerland, Spain, and Chile. A total of 1463 women of any age with BC up to 2 cm and a negative preoperative axillary ultrasonography result were enrolled and randomized between February 6, 2012, and June 30, 2017. Of those, 1405 were included in the intention-to-treat analysis. Data were analyzed from October 10, 2022, to January 13, 2023.InterventionEligible patients were randomized on a 1:1 ratio to receive SLNB (SLNB group) or no axillary surgery (no axillary surgery group).Main outcomes and measuresThe primary end point of the study was distant disease-free survival (DDFS) at 5 years, analyzed as intention to treat. Secondary end points were the cumulative incidence of distant recurrences, the cumulative incidence of axillary recurrences, DFS, overall survival (OS), and the adjuvant treatment recommendations.ResultsAmong 1405 women (median [IQR] age, 60 [52-68] years) included in the intention-to-treat analysis, 708 were randomized to the SLNB group, and 697 were randomized to the no axillary surgery group. Overall, the median (IQR) tumor size was 1.1 (0.8-1.5) cm, and 1234 patients (87.8%) had estrogen receptor-positive ERBB2 (formerly HER2 or HER2/neu), nonoverexpressing BC. In the SLNB group, 97 patients (13.7%) had positive axillary nodes. The median (IQR) follow-up for disease assessment was 5.7 (5.0-6.8) years in the SLNB group and 5.7 (5.0-6.6) years in the no axillary surgery group. Five-year distant DDFS was 97.7% in the SLNB group and 98.0% in the no axillary surgery group (log-rank P = .67; hazard ratio, 0.84; 90% CI, 0.45-1.54; noninferiority P = .02). A total of 12 (1.7%) locoregional relapses, 13 (1.8%) distant metastases, and 21 (3.0%) deaths were observed in the SLNB group, and 11 (1.6%) locoregional relapses, 14 (2.0%) distant metastases, and 18 (2.6%) deaths were observed in the no axillary surgery group.Conclusions and relevanceIn this randomized clinical trial, omission of axillary surgery was noninferior to SLNB in patients with small BC and a negative result on ultrasonography of the axillary lymph nodes. These results suggest that patients with these features can be safely spared any axillary surgery whenever the lack of pathological information does not affect the postoperative treatment plan.Trial registrationClinicalTrials.gov Identifier: NCT02167490.

Project description:Objective:Biopsy markers are often placed into biopsy-proven metastatic axillary lymph nodes to ensure later accurate node excision. Ultrasound is the preferred imaging modality in the axilla. However, sonographic identification of biopsy markers after neoadjuvant therapy can be challenging. This is due to poor conspicuity relative to surrounding parenchymal interfaces, treatment-related alteration of malignant morphology during neoadjuvant chemotherapy, or extrusion of the marker from the target. To the authors' knowledge, the literature provides no recommendations for ultrasound scanning parameters that improve the detection of biopsy markers. The purpose of this manuscript is 3-fold: (1) To determine scanning parameters that improve sonographic conspicuity of biopsy markers in a phantom and cadaver model; (2) to implement these scanning parameters in the clinical setting; and (3) to provide strategies that might increase the likelihood of successful ultrasound detection of biopsy markers in breast imaging practices. Materials and Methods:An ex vivo study was performed using a phantom designed to simulate the heterogeneity of normal mammary or axillary soft tissues. A selection of available biopsy markers was deployed into this phantom and ultrasound (GE LOGIQ E9) was performed. Scanning parameters were adjusted to optimize marker conspicuity. For the cadaver study, the biopsy markers were deployed using ultrasound guidance into axillary lymph nodes of a female cadaver. Adjustments in transducer frequency, dynamic range, cross-beam (spatial compound imaging), beam steering, speckle reduction imaging, harmonic imaging, colorization, and speed of sound were evaluated. Settings that improved marker detection were used clinically for a year. Results:Sonographic scanning settings that improved biopsy marker conspicuity included increasing transducer frequency, decreasing dynamic range, setting cross-beam to medium hybrid, turning on beam steering, and setting speckle reduction imaging in the mid-range. There was no appreciable improvement with harmonic imaging, colorization, or speed of sound. Conclusion:On a currently available clinical ultrasound scanning system, ultrasound scanning parameters can be adjusted to improve the conspicuity of biopsy markers. Overall, optimization requires a balance between techniques that clinically increase contrast (dynamic range, harmonic imaging, and steering) and those that minimize graininess (spatial compound imaging, speckle reduction imaging, and steering). Additional scanning and procedural strategies have been provided to improve the confidence of sonographic detection of biopsy markers closely associated with the intended target.

Dataset Information

Enhanced pre-operative axillary staging using intradermal microbubbles and contrast-enhanced ultrasound to detect and biopsy sentinel lymph nodes in breast cancer: a potential replacement for axillary surgery.

Publications

Enhanced pre-operative axillary staging using intradermal microbubbles and contrast-enhanced ultrasound to detect and biopsy sentinel lymph nodes in breast cancer: a potential replacement for axillary surgery.

Similar Datasets

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