Project description:BACKGROUND: Currently employed techniques for the localization of nonpalpable breast lesions suffer from various limitations. In this paper, we report on 2 patients in order to introduce an alternative technique, indocyanine green fluorescence-guided occult lesion localization (IFOLL), and determine its applicability for the surgical removal of this type of breast lesions. CASE REPORTS: Preoperatively, one of the patients had a needle biopsy-proven diagnosis of breast cancer, and the other one had suspicious findings for malignancy. Lesion localization was performed within 1 h before surgery under ultrasonography control by injecting 2 ml and 0.2 ml of indocyanine green into the lesion and its subcutaneous tissue projection, respectively. During surgery, the site of skin incision and the resection margins were identified by observing the area of indocyanine-derived fluorescence under the guidance of a near-infrared-sensitive camera. In both cases, the breast lesion was correctly localized, and the area of fluorescence corresponded well to the site of the lesions. Subsequent surgical excision was successful with no complications. On histopathologic examination, the surgical margins were found to be clear. CONCLUSION: IFOLL seems to be a technically applicable and clinically acceptable procedure for the removal of nonpalpable breast cancer.
Project description:With the increasing number of non palpable breast carcinomas, the need of a good and reliable localization method increases. Currently the wire guided localization (WGL) is the standard of care in most countries. Radio guided occult lesion localization (ROLL) is a new technique that may improve the oncological outcome, cost effectiveness, patient comfort and cosmetic outcome. However, the studies published hitherto are of poor quality providing less than convincing evidence to change the current standard of care. The aim of this study is to compare the ROLL technique with the standard of care (WGL) regarding the percentage of tumour free margins, cost effectiveness, patient comfort and cosmetic outcome.The ROLL trial is a multi center randomized clinical trial. Over a period of 2-3 years 316 patients will be randomized between the ROLL and the WGL technique. With this number, the expected 15% difference in tumour free margins can be detected with a power of 80%. Other endpoints include cosmetic outcome, cost effectiveness, patient (dis)comfort, degree of difficulty of the procedures and the success rate of the sentinel node procedure. The rationale, study design and planned analyses are described.(http://www.clinicaltrials.gov, study protocol number NCT00539474).
Project description:This paper describes a new nuclear imaging agent, 2-(4-isothiocyanatobenzyl)-1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid of human albumin (HAC), potentially suitable for application in the Radio-guided Occult Lesion Localization (ROLL) of non-palpable mammalian cancerous lesions, as a tool to overtake the short radio-signal half-life of the technetium-99m based radiopharmaceutical currently used. This conjugate is a microsized powder aggregate, water-insoluble between pH 3 and 8.5, obtained by conjugating the protein with the macrocyclic chelating agent DOTA through a one-pot reaction in aqueous medium. The product has been fully characterized and is stable to the thermal conditions adopted for labeling; after radiolabeling with longer half-life radionuclides such as 177Lu or 111In, it has shown radiochemical purity (RCP) >90% and resulted stable when stored in saline or plasma for 6 days at 37 °C. A μPET/CT study, performed in vivo on adult female rats, showed that the radioactivity of HAC labeled with 64Cu remained located in the mammary glands for at least 40 h, without diffusion or drainage in healthy tissues or in the lymphatic circulation. This new imaging agent might make the ROLL procedure more accessible, safe and flexible, promoting a significant time and cost reduction of this intervention. Moreover, HAC might also be used in other radio-guided surgical procedures in oncology.
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:Background The varying experience of surgeons and ultrasound physicians, and their collaboration with physicians, may affect operation time and efficiency. We evaluated the learning curve of ultrasound-guided vacuum-assisted excision (VAE) of breast lesion with collaboration between different physicians, and assessed characteristics associated with operation time. Methods The sample population of this retrospective study was divided into two groups: 49 consecutive patient surgeries completed by skilled surgeons and novice ultrasound physicians (U group); and 30 consecutive patient surgeries completed by skilled ultrasound physicians and novice surgeons (S group). Cumulative summation graphs were used to evaluate operation time and calculate the turning point of the learning curve. Patients in the U and S groups were divided into exploration stage and proficiency stage according to the turning point, and the differences in influencing factors were compared. A total of 548 patients who underwent vacuum-assisted breast excision performed by a combination of skilled surgeons and skilled ultrasound physicians were selected as the reference group (R group). The differences among the three groups were compared. The relationship between the operation time and other factors in the different groups was analyzed using linear regression. Results The best learning curve of the sample population was the quadratic fitting equation, and the turning point was the 19th case in the U group and the 14th case in the S group. The total operation times in the proficiency stage were significantly shorter than those in the exploration stage in the U and S groups (P=0.012 and P=0.003, separately). Patient age, long diameter, short diameter, and depth of masses related to the operation time. Conclusions Our data suggest the existence of different learning curves in ultrasound-guided vacuum-assisted excision for the collaborations of different stages surgeons and ultrasound physicians. Through the accumulation of experience, it is feasible to safely perform ultrasound-guided VAE of breast lesions.
Project description:BackgroundThis study is a systematic review with meta-analysis comparing radioactive seed localization (RSL) versus radio-guided occult lesion localization (ROLL) and wire-guided localization (WGL) for patients with impalpable breast cancer undergoing breast-conserving surgery and evaluating efficacy, safety, and logistical outcomes. The protocol is registered in PROSPERO with the number CRD42022299726.MethodsA search was conducted in the Embase, Lilacs, Pubmed, Scielo, Web of Science, and clinicaltrials.gov databases, in addition to a manual search in the reference list of relevant articles, for randomized clinical trials and cohort studies. Studies selected were submitted to their own data extraction forms and risk of bias analysis according to the ROB 2 and ROBINS 1 tools. A meta-analysis was performed, considering the random effect model, calculating the relative risk or the mean difference for dichotomous or continuous data, respectively. The quality of the evidence generated was analyzed by outcome according to the GRADE tool. Overall, 46 articles met the inclusion criteria and were included in this systematic review; of these, 4 studies compared RSL and ROLL with a population of 1550 women, and 43 compared RSL and WGL with a population of 19,820 women.ResultsThe results showed that RSL is a superior method to WGL in terms of surgical efficiency in the impalpable breast lesions' intraoperative localization, and it is at least equivalent to ROLL. Regarding security, RSL obtained results equivalent to the already established technique, the WGL. In addition to presenting promising results, RSL has been proven to be superior to WGL and ROLL technologies.
Project description:The role of ultrasound-guided interventions in the diagnosis and treatment of breast lesions is gaining importance and prevalence, particularly as the instances of non-palpable breast lesion detection, breast-conserving surgery, and neoadjuvant chemotherapy are increasing. This review attempts to summarize the types and techniques of breast ultrasound-guided interventional procedures, such as biopsy, tissue marker insertion, and preoperative localization, and their indications. Furthermore, we highlight the pro and cons of the most commonly used procedures with the intention of promoting their use in clinical practice.
Project description:BackgroundThe radioactive seed localization (RSL) is used in impalpable breast cancer conservative surgery to assist the surgeon in accurately locating and excising the lesion site. This study aims to present recommendations about the RSL program implementation in health institutions that perform breast cancer conservative surgery with intraoperative localization.MethodsAn extensive literature review was performed. It comprehends: the committee responsible for implementation of the program actions; description of the necessary multidisciplinary team; the radiological safety committee role; the facility licensing; professionals training; material and instrumentation associated with the technique; and seed tracking system.Results13 topics are presented. The Program Implementation Committee must be formed by leaders from each department. The committee assumes responsibility for evaluating the necessary processes and presenting the schedule for program implementation. Since the procedure is classified as a nuclear medicine procedure it requires licensing. The Professional Team Formation, Education, and Training is a priority and simulation exercises are necessary. The Materials and Instrumentation Associated with the Technique must be well-know by the team and they should practice using radiation detectors. The seed must be always tracked, from moment they are received to discard. An Inventory for Tracking Seeds is provided. The Radiological Safety Aspects such as the ALARA principle are presented. A full description for the Radiological Procedure for Placing the seeds, the surgical removal and the Specimen Handling in Pathology focusing on how to locate the seed and retrieve them. After removed, the seeds can be placed in storage to wait for full radioactive decay or be returned to the manufacturer.ConclusionsThe procedure has the advantage to increase to 2 months the time between insertion of the seed and the surgical removal. Regular multidisciplinary team meetings during program development are important to create a realistic timeline, having briefing meetings after the first 1-5 RSL cases and having annual or biannual follow-up meetings to discuss any issues or incidents. Abstract Graphic ImageCreated by Macrovector, obtained in Freepik at https://br.freepik.com/fotos-vetores-gratis/oncologia.This graphical abstract shows everything that is necessary to implement the RSL technique and are discussed in this paper.HighlightsThis study present recommendations for RSL program implementation in hospitalsWas performed by an extensive descriptive and qualitative literature reviewTopics 1: Implementation Committee, Professional Team Training, InstrumentationTopics 2: Radiological Safety, Patient Consent, Radiological ProcessTopics 3: Surgical Procedure, Pathology, Seeds Disposal Completion.
Project description:Percutaneous biopsy is the standard of care for breast lesions, except nipple lesions which are primarily biopsied by excision due to perceived risks of pain and bleeding. However, excisional biopsy of nipple lesion inevitably leads to disfigurement and possible loss of the nipple-areolar complex (NAC), highlighting the need for minimally invasive biopsy techniques. We present our experience of seven patients who underwent ultrasound-guided core biopsy or vacuum-assisted biopsy (VAB) for sampling of clinically occult nipple lesions. All patients tolerated the biopsy procedures well with minimal to mild pain. A patient was complicated by a subcentimetre skin laceration which was sutured with good wound healing and cosmesis. Radiopathological concordance was achieved in all patients. Five out of 7 patients did not require further surgical management after biopsy, avoiding the unnecessary disfigurement from conventional excisional biopsy of nipple. The remaining two patients were diagnosed with pre-malignant lesions and further surgical treatment was performed. This study highlights the important pre-procedural preparation, biopsy techniques and learning points derived from our experience. Learning points that increase the efficacy of obtaining suitable tissue samples, such as enhancing lesion visualisation, appropriate biopsy needle selection and optimising analgesia were discussed. Potential complications and common pitfalls, such as mimics of nipple calcifications, were also included. In conclusion, image-guided percutaneous biopsy techniques are feasible minimally invasive alternatives to excisional biopsy of the nipple.
Project description:The evaluation of loco-regional lymph nodes (LN) plays an important prognostic role and assists the clinical decision making in canine cancer patients. Excision of non-palpable LN can be challenging. The aim of the study was to evaluate surgical time, successful excision rate and surgical complications associated with the use of an ultrasound-guided hook-wire (UGHW) LN localization method for non-palpable superficial inguinal LN (SILN) in dogs. Dogs that presented for excision of non-palpable SILN, performed with the aid of an UGHW placement, were enrolled. Information including signalment, SILN width, UGHW placement and surgical procedure time, hook-wire position, successful excision and intra- and post-operative complications were reviewed. Seventeen dogs were enrolled. Median LN width was 3 mm (range 2-11). Median time of preoperative UGHW placement and surgical LN excision was 8 min and 15 min, respectively. Successful SILN excision was achieved in all cases. Two minor intra-operative (hook migration and wire fragmentation) and one minor post-operative complications (seroma) were observed. No major intraoperative or post-operative complications occurred. The UGHW LN localization method is safe and effective and may allow a high rate of successful SILN excisions in dogs. This method has the potential to facilitate LN excision for other superficial LN locations.