Localisation accuracy with iodine-125 seed versus wire guidance for breast cancer surgery.

INTRODUCTION: Impalpable breast lesions generally require image-guided localisation for breast-conserving surgery. A standard technique is to place a hook wire (HW) within the lesion. Radioguided occult lesion localisation using iodine seeds (ROLLIS) involves inserting a 4.5 mm iodine-125 seed (seed) into the lesion. We hypothesised that a seed could be more precisely positioned in relation to the lesion than a HW and that this may be associated with a lower re-excision rate. METHODS: Retrospective review of consecutive participant data from three ROLLIS RCT (ACTRN12613000655741) sites. Participants underwent preoperative lesion localisation (PLL) with seed or HW between September 2013 and December 2017. Lesion and procedural characteristics were recorded. Distances between (1) any part of the seed or thickened segment of the HW ('TSHW') and the lesion/clip ('distance to device' DTD) and (2) centre of the TSHW/seed and centre of the lesion/clip (device centre to target centre 'DCTC') were measured on immediate postinsertion mammograms. Pathological margin involvement and re-excision rates were compared. RESULTS: A total of 390 lesions (190 ROLLIS and 200 HWL) were analysed. Lesion characteristics and guidance modality used were similar between groups. Ultrasound-guided DTD and DCTC for seed were smaller than for HW (77.1% and 60.6%, respectively, P-value < 0.001). Stereotactic-guided DCTC for seeds was 41.6% smaller than for HW (P-value = 0.001). No statistically significant difference in the re-excision rates was found. CONCLUSION: Iodine-125 seeds can be more precisely positioned for preoperative lesion localisation than HW, however, no statistically significant difference in re-excision rates was detected.

ROLLIS roll-out: Pitfalls, errors, lessons learned and recommendations from Australian and New Zealand experience during the randomised controlled trial, implementing a novel localisation method for impalpable malignant breast lesions, radio-guided occult lesion localisation with iodine-125 (125 I) seed (ROLLIS).

INTRODUCTION: Breast cancer surgery aims to excise lesions with clear margins and provide optimal cosmesis with a low re-excision rates. These aims are aided by accurate lesion localisation and a surgical choice of incision site with minimal removal of healthy tissue. Problems associated with hookwires have led to adoption of non-wire methods including radioguided occult lesion localisation using iodine-125 (ROLLIS). This paper outlines the problems encountered and lessons learnt during the largest RCT involving 659 participants, conducted at eight sites (seven Australian, one New Zealand centres) between September 2013 and April 2018.* METHODS: Data, along with substantive comments, regarding each ROLLIS procedure, documenting each step from the seed insertion, ease of operative retrieval, to return of the seed to medical physics, from a shared on-line secure database and a separate site email survey, were synthesised and categorised. RESULTS: The Australian and New Zealand ROLLIS RCT experience highlights several important issues. Lessons learned were related to licencing the seed and tracking protocols. A Designated Team Lead, who is a good communicator, ensuring the Tracking Protocols were accurately followed and updated, subspecialty leads and a Co-ordinator, responsible for training, logbook maintenance and seed ordering, enhanced the success and acceptance of the programme. Addressing radiation issues, fears, education of staff and seed loss was imperative. CONCLUSION: The Australian and New Zealand ROLLIS RCT experience highlights the need for adherence to local licencing laws and protocols, appointing a dedicated ROLLIS Designated Team Lead with good communication and a ROLLIS Co-ordinator. These facilitate the adoption of a successful ROLLIS programme.

Can micro-computed tomography imaging improve interpretation of macroscopic margin assessment of specimen radiography in excised breast specimens?

INTRODUCTION: Peri-operative macroscopic margin assessment with standard intraoperative specimen radiography (IOSR) results in improved re-excision rates in excised breast tissue specimens but is limited. This study sought to improve the intraoperative margin assessment on standard IOSR techniques by utilizing noninvasive X-ray micro-computed tomography (micro-CT) imaging of breast tissue specimens to compare margins in three-dimensional with two-dimensional IOSR. METHODS: Patients with impalpable breast carcinoma, or suspected breast carcinoma, who were eligible for breast-conserving surgery were recruited. Margins were assessed within each specimen using standard IOSR, micro-CT, and histology techniques. RESULTS: Six malignant and three benign lesions were included for the analysis in this study. Micro-CT identified the same positive margin as IOSR in 3 out of 6 malignancies. However, margin status identified by micro-CT was concordant with pathological assessment in only one specimen. In comparison, margin assessment by IOSR correctly correlated with pathological margin status in three malignant specimens. CONCLUSION: The use of micro-CT imaging in this study did not improve margin assessment in impalpable breast specimens when compared to standard specimen radiography (SR) assessment. However, future improvements in sample preparation and CT image acquisition processes may enhance the potential of micro-CT as a valuable imaging tool for improving margin assessment.

The technique and accuracy of breast specimen ultrasound in achieving clear margins in breast conserving surgery.

INTRODUCTION: The aim of this prospective study was to determine whether breast specimen ultrasound (SUS) can reliably be used to confirm whether ultrasound (US) visible breast malignancies are excised with clear margins during breast-conserving surgery (BCS), in order to avoid a second operation and recurrence. METHODS: A total of 95 consecutive participants with US visible malignancies, undergoing BCS, had the excised breast specimen transported to the radiology department intraoperatively. Breast SUS was used to confirm the presence of the lesion and measure the medial, lateral, superior and inferior margins. Margins < 10mm prompted a call to theatre to recommend an immediate cavity shave. The accuracy of the SUS technique in confirming the lesion is contained within the specimen, and the correlation of radial margins on US and histology was assessed retrospectively. RESULTS: Breast SUS had 100% accuracy in confirming the presence of 99 lesions. 384 corresponding US and invasive carcinoma histological margins were compared. A 10mm or greater margin on US has a sensitivity of 56% (95% CI 21-86), specificity of 93% (95% CI 90-95) and accuracy of 92% (95% CI 89-95) in predicting no ink on tumour histologically, with a positive predictive value of 16% (95% CI 5-34) and negative predictive value of 99% (95% CI 97-99%). The area under the curve was 0.746 (95% CI 0.572-0.921). CONCLUSIONS: Breast SUS is a fast and reliable technique. Mammographically occult breast malignancies that are sonographically evident should undergo SUS to confirm the presence of the lesion and assess its macroscopic margins to avoid a re-excision.

Comparison of the time taken for localised breast surgery pre- and post-introduction of intra-operative digital specimen mammography.

INTRODUCTION: More than half of the patients with an impalpable malignant breast lesion have a mammographically detected and imaged-guided localisation, which can be technically challenging for the breast surgeon. Specimen imaging is used to confirm successful excision of the localised index lesion and has improved the operating list efficiency resulting in a higher number of excisions per surgical list. The aim of this study was to evaluate whether introducing IDSM (intra-operative digital specimen mammography) saved operation time for localised breast surgery. METHODS: A single-centre retrospective review was undertaken to compare the operation time (from incision to wound closure) taken for excision of 114 consecutive image-guided localised impalpable breast lesions, performed using departmental specimen radiography (DSR), 6 months prior to the introduction of IDSM (Hologic, Trident® ) in March 2013, with the theatre time taken for excision of 121 consecutive image-guided localised impalpable breast lesions in the 6 months following introduction of IDSM. RESULTS: There was no significant difference in mean surgical time, which were 47.8 (±27.3) minutes in the CSR group and 48.8 (±25.7) minutes in the IDSM group. CONCLUSION: We were expecting to confirm a reduction in theatre time with the introduction of IDSM. Surprisingly, no difference in operating times was demonstrated. Factors that influenced the impact of IDSM included the proximity of the imaging department to the operating theatre.

Patient satisfaction with Radioguided Occult Lesion Localisation using iodine-125 seeds ('ROLLIS') versus conventional hookwire localisation.

BACKGROUND: Women with impalpable or poorly palpable breast cancer require radiologically guided localisation prior to breast conserving surgery. Radioguided Occult Lesion Localisation using Iodine-125 Seed (ROLLIS) is an emerging alternative to conventional Hookwire Localisation (HWL). We compared ROLLIS with conventional HWL with respect to patient reported stress and discomfort related to the localisation procedure. PATIENTS AND METHODS: From September 2013 to January 2016, women who were eligible for breast conserving surgery with impalpable or poorly palpable histologically confirmed invasive or in-situ carcinoma were recruited to the multi-centre ROLLIS randomised controlled trial and underwent either ROLLIS or HWL. Following surgery, a questionnaire was administered to each participant regarding the stress and discomfort related to the localisation procedure. Multivariate analysis was performed to compare the primary outcome of patient-reported stress and discomfort between localisation groups. RESULTS: 218 participants with 220 lesions were randomised and underwent breast conserving surgery following localisation. 201 (92.2%) and 202 (92.7%) of participants provided responses to the stress and discomfort components of the questionnaire respectively. HWL was associated with a statistically significant increased odds of greater stress and discomfort when compared to ROLLIS (OR = 2.07, p = 0.01 and OR = 1.94, p = 0.01 respectively). Insertion of multiple localisation devices was also associated with increased stress (OR = 5.68, p < 0.01) and discomfort (OR = 2.96, p < 0.01). CONCLUSION: When compared with conventional HWL, ROLLIS is associated with significantly less stress and discomfort for patients prior to breast conserving surgery.

Iodine-125 seeds to guide removal of impalpable breast lesions: radio-guided occult lesion localization - a pilot study.

BACKGROUND: The aim of this study was to confirm that radio-guided occult lesion localization using low activity iodine 125 (I-125) seeds (ROLLIS) could be safely and accurately used for localization and guided excision of impalpable breast lesions in different multidisciplinary settings and to prepare staff for a randomized controlled trial. METHOD: Preoperative image-guided localization of 102 lesions using one or two I-125 seeds with hook-wire back-up was performed in 99 participants at two tertiary hospitals. Preoperative core biopsy in 24 lesions was benign or indeterminate (Group A) and malignant in 78 lesions (Group B). Imaging and histopathology findings and re-excision rates were recorded. Training requirements for new staff and seed handling protocols were refined. RESULTS: All seeds and lesions were successfully removed. In five of 23 Group A participants, malignancy on final pathology required definitive surgery for positive margins. The re-excision rate in Group B was 17%. Overall re-excision rate was 18%. Thirty-seven clinical staff members were trained. Sentinel node localization was successful in all 76 cases. Seeds of low activity were successfully used. CONCLUSION: The ROLLIS technique using a lower dose (∼2 MBq) seed is safe, effective and can easily be adopted in a large multi-disciplinary setting.

Predictors of re-excision in wire-guided wide local excision for early breast cancer: a Western Australian multi-centre experience.

BACKGROUND: A significant proportion of breast cancers present as impalpable lesions requiring radiological guidance prior to surgical excision, commonly by hook-wire placement. Complete lesion excision is an essential part of treatment, and re-excision may be needed to ensure this and minimize local recurrence. We explore a 1-year audit of re-excision of hook-wire-guided excisions in two large public breast units in Western Australia and define factors associated with the requirement for re-excision. METHODS: A retrospective review of wire-localized wide local excisions for early breast cancer in 2009 at two tertiary breast centres in Western Australia. RESULTS: Of 148 localized lesions, 44 (30%) underwent re-excision. The only significant preoperative finding was the location of tumour in the breast. The intra-operative specimen radiograph provided useful information that influenced re-excision. Smaller (≤5 mm) and larger (>20 mm) tumours on final pathological size were more likely to undergo re-excision as well as a larger difference in actual size to predicted size. The presence of ductal carcinoma in situ (DCIS) increased re-operation, as did multifocality. CONCLUSION: This study highlights factors that should make the surgeon more cautious for re-excision. Suspicion of DCIS, especially at the periphery of tumours, and a central tumour location increase risk. Lesion localization techniques play an important role in minimizing risk while maintaining cosmesis.

Radioguided occult lesion localisation using iodine-125 seeds ('ROLLIS') for removal of impalpable breast lesions: First Australian experience.

INTRODUCTION: Approximately one-third of breast cancers are impalpable and require pre-operative image-guided localisation. Hook-wire localisation (HWL) is commonly used but has several disadvantages. Use of a low-activity radioactive iodine-125 seed is a promising alternative technique used in the USA and the Netherlands. This pilot study describes the first use of this in Australia. METHODS: In this prospective pilot study, 21 participants with biopsy-proven breast cancer underwent radioguided occult lesion localisation using iodine-125 seed(s) (ROLLIS) with insertion of a hook-wire for back up. Sentinel node biopsy was performed where indicated. Ease of hook-wire and seed insertion, duration of the procedure, dependence on the seed versus hook-wire during surgery, lesion location within the specimen, histopathology including size of radial margins, the ease of seed retrieval in pathology, and safe return of seeds for disposal were documented. Radiation dosimetry of staff was performed. RESULTS: All seeds were placed within 3.5 mm of the lesion. All lesions and seeds were removed. One participant needed re-excision for involved margins. Radiologists and surgeons both preferred ROLLIS. Surgeons were able to depend on the seed for localisation in all but one case. Sentinel node biopsy was successfully performed when required. Pathologists found seed retrieval quick and easy, with no detrimental effect on tissue processing. No radiation doses measurably above background were received by staff. CONCLUSION: ROLLIS is an easily learnt, safe and effective alternative technique to standard HWL.

Malignant phyllodes tumour presenting as a massive fungating breast mass and silent thrombo-embolism.

INTRODUCTION: We report an unusual case of a massive malignant phyllodes tumour that had almost replaced the entire breast presenting with severe chronic blood loss, extensive deep venous thrombosis (DVT) and a silent pulmonary embolus. PRESENTATION: Long-standing neglected massive fungating ulcerative mass larger than the left haemothorax. DISCUSSION: Phyllodes tumours are rare fibro-epithelial breast lesions that have the propensity to grow rapidly to a large size if neglected. Larger tumours are more likely to be malignant with an overall metastatic rate around 10%. An incidental pulmonary embolus arising from extensive silent lower limb deep vein thrombosis requiring an IVC filter complicated the surgical management. CONCLUSION: Phyllodes tumours are rare and account for approximately 0.3-0.5% of all breast tumours [1]. They have the propensity to be fast growing. However, tumours reaching a massive size (>10cm) are rare with few reports in the literature.

Ultrasound-guided optical coherence tomography needle probe for the assessment of breast cancer tumor margins.

OBJECTIVE: The purpose of this study was to evaluate a new imaging technique for the assessment of breast cancer tumor margins. The technique entails deployment of a high-resolution optical imaging needle under ultrasound guidance. Assessment was performed on fresh ex vivo tissue samples. CONCLUSION: Use of the ultrasound-guided optical needle probe allowed in situ assessment of fresh tissue margins. The imaging findings corresponded to the histologic findings.