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Pinero-Madrona A.,University of Murcia | Torro-Richart J.A.,Lluis Alcanyis Hospital | de Leon-Carrillo J.M.,University of Seville | de Castro-Parga G.,University of Vigo | And 5 more authors.
European Journal of Surgical Oncology | Year: 2015

Aims: The gold standard for detection of Sentinel Lymph Nodes (SLN) is a combined radioisotope and blue dye breast injection, using a gamma probe (GP). A new, non-radioactive method was developed, using a tracer (Sienna+®) of superparamagnetic iron oxide (SPIO) nanoparticles and a manual magnetometer (SentiMag®) (SM). The IMAGINE study was designed to show the non-inferiority of SM compared to GP, for the detection of SLN in breast cancer patients with SLN biopsy indication. Methods: From November 2013 to June 2014, 181 patients were recruited, and 321 nodes were excised and assessed ex-vivo. Readings from both SM and GP devices were recorded during transcutaneous, intraoperative, and ex-vivo detection attempts. Results: At the patient level, ex-vivo detection rates (primary variable) with SM and GP were 97.8% and 98.3% (concordance rate 99.4%). Transcutaneous and intraoperative detection rates were 95.5% vs 97.2%, and 97.2% vs 97.8% for SM and GP respectively (concordance rates>97%). At the node level, intraoperative and ex-vivo detection rates were 92.5% vs 89.3% and 91.0% vs 86.3% for SM and GP respectively. In all cases the non-inferiority of SM compared to SM was shown by ruling out a predefined non-inferiority margin of 5%. Conclusions: Our study showed the non-inferiority of SM as compared to GP. Moreover, the ex-vivo and intraoperative detection rates at the node level were slightly higher with SM. © 2015 Elsevier Ltd.


Pinero-Madrona A.,University of Murcia | Torro-Richart J.A.,Lluis Alcanyis Hospital | De Leon-Carrillo J.M.,University of Seville | De Castro-Parga G.,University of Vigo | And 5 more authors.
European Journal of Surgical Oncology | Year: 2015

Aims The gold standard for detection of Sentinel Lymph Nodes (SLN) is a combined radioisotope and blue dye breast injection, using a gamma probe (GP). A new, non-radioactive method was developed, using a tracer (Sienna+®) of superparamagnetic iron oxide (SPIO) nanoparticles and a manual magnetometer (SentiMag®) (SM). The IMAGINE study was designed to show the non-inferiority of SM compared to GP, for the detection of SLN in breast cancer patients with SLN biopsy indication. Methods From November 2013 to June 2014, 181 patients were recruited, and 321 nodes were excised and assessed ex-vivo. Readings from both SM and GP devices were recorded during transcutaneous, intraoperative, and ex-vivo detection attempts. Results At the patient level, ex-vivo detection rates (primary variable) with SM and GP were 97.8% and 98.3% (concordance rate 99.4%). Transcutaneous and intraoperative detection rates were 95.5% vs 97.2%, and 97.2% vs 97.8% for SM and GP respectively (concordance rates > 97%). At the node level, intraoperative and ex-vivo detection rates were 92.5% vs 89.3% and 91.0% vs 86.3% for SM and GP respectively. In all cases the non-inferiority of SM compared to SM was shown by ruling out a predefined non-inferiority margin of 5%. Conclusions Our study showed the non-inferiority of SM as compared to GP. Moreover, the ex-vivo and intraoperative detection rates at the node level were slightly higher with SM. © 2015 Elsevier Ltd.


PubMed | University of Castilla - La Mancha, University of Valencia, Hospital Complex of Navarra, Hospital Complex of Jaen and 5 more.
Type: Comparative Study | Journal: European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology | Year: 2015

The gold standard for detection of Sentinel Lymph Nodes (SLN) is a combined radioisotope and blue dye breast injection, using a gamma probe (GP). A new, non-radioactive method was developed, using a tracer (Sienna+()) of superparamagnetic iron oxide (SPIO) nanoparticles and a manual magnetometer (SentiMag()) (SM). The IMAGINE study was designed to show the non-inferiority of SM compared to GP, for the detection of SLN in breast cancer patients with SLN biopsy indication.From November 2013 to June 2014, 181 patients were recruited, and 321 nodes were excised and assessed ex-vivo. Readings from both SM and GP devices were recorded during transcutaneous, intraoperative, and ex-vivo detection attempts.At the patient level, ex-vivo detection rates (primary variable) with SM and GP were 97.8% and 98.3% (concordance rate 99.4%). Transcutaneous and intraoperative detection rates were 95.5% vs 97.2%, and 97.2% vs 97.8% for SM and GP respectively (concordance rates > 97%). At the node level, intraoperative and ex-vivo detection rates were 92.5% vs 89.3% and 91.0% vs 86.3% for SM and GP respectively. In all cases the non-inferiority of SM compared to SM was shown by ruling out a predefined non-inferiority margin of 5%.Our study showed the non-inferiority of SM as compared to GP. Moreover, the ex-vivo and intraoperative detection rates at the node level were slightly higher with SM.


Fdez-Olivares J.,University of Granada | Sanchez-Garzon I.,University of Granada | Gonzalez-Ferrer A.,University of Granada | Cozar J.A.,Hospital Complex of Jaen | And 3 more authors.
Lecture Notes in Computer Science (including subseries Lecture Notes in Artificial Intelligence and Lecture Notes in Bioinformatics) | Year: 2012

In this paper we present a knowledge-based, Clinical Decision Support System (OncoTheraper2.0) that provides support to the full life-cycle of both clinical decisions and clinical processes execution in the field of pediatric oncology treatments. The system builds on a previous proof of concept devoted to demonstrate that Hierarchical Planning and Scheduling is an enabling technology to support clinical decisions. The present work describes new issues about the engineering process carried out in the development and deployment of the system in a hospital environment (supported by a knowledge engineering suite named IActive Knowledge Studio, devoted to the development of intelligent systems based on Smart Process Management technologies). New techniques that support the execution and monitoring of patient-tailored treatment plans, as well as, the adaptive response to exceptions during execution are described. © 2012 Springer-Verlag.


PubMed | Hospital Complex of Jaen, Autonomous University of Barcelona and University of Salamanca
Type: | Journal: Breast (Edinburgh, Scotland) | Year: 2016

Sentinel lymph node (SLN) biopsy has been shown to be both accurate and feasible for women who receive neoadjuvant chemotherapy (NAC). Intraoperative assessment of SLN by frozen sections can produce false negative results. The aim of this study was to compare two different techniques of intraoperative assessment of SLN in breast cancer patients treated with NAC: frozen section (FS) and molecular assay (OSNA).A multicenter cohort of 320 consecutive breast cancer patients treated with NAC between 2010 and 2014 was analyzed. FS was performed intraoperatively in 166 patients (H&E cohort) and OSNA in 154 patients (OSNA cohort).A mean of 2.15 SLNs by FS and 1.22 SLNs by OSNA was assessed (p=0.03). SLN metastasis was found in 44 patients (26.5%) by FS and in 48 (31.2%) by OSNA (p=0.4). There was no statistical significance in rates of macrometastasis (75%), micrometastasis (20.5%) or ITCs (4.5%) when assessed by FS compared to OSNA (52.3%, 36.3% and 11.4%, respectively) (p=0.06). There were 10 patients in the H&E cohort with positive-SLN in the definitive pathology assessment with negative intraoperative FS. When OSNA and definitive pathology were compared, there were no differences in rates of macrometastasis (61.1%), micrometastasis (33.3%) nor ITCs (5.6%) (p=0.5). Fifty-four patients in the H&E cohort and 44 in the OSNA cohort had ALND after positive-SLNs. ALND was performed in a second surgery in 10 patients (18.5%) in the H&E cohort for intraoperative FS false negative results, 90% being micrometastasis. 42 out of 44 patients (95.5%) in the OSNA cohort had an ALND in the same surgery (p=0.03).OSNA assay detects SLNs metastases as accurately as conventional pathology in the NAC setting. Intraoperative definitive assessment of the SLN by OSNA reduces the need for a second surgery for ALND in 18.5% of breast cancer patients with a positive-SLN after NAC.


Navarro-Cecilia J.,Hospital Complex of Jaen | Duenas-Rodriguez B.,Hospital Complex of Jaen | Duenas-Rodriguez B.,University of Jaén | Luque-Lopez C.,Hospital Complex of Jaen | And 8 more authors.
European Journal of Surgical Oncology | Year: 2013

Background There is no evidence that supports the recommendation of sentinel lymph node biopsy (SLNB) in patients with breast cancer who have treated with neoadjuvant chemotherapy (NAC) to downsize tumors in order to allow breast conservation surgery, because NAC induces anatomical alterations of the lymphatic drainage. We evaluated the effectiveness of SLNB using intraoperative one-step nucleic acid amplification (OSNA) method to detect microscopic metastases or isolated tumor cells after NAC in patients with clinically negative axillary nodes at initial presentation. Patients and methods We evaluated in patients with breast cancer and clinically negative axilla at presentation, the effectiveness of SLNB by OSNA after NAC (71 patients) or prior to NAC (40 patients). Results The rate of SLN identification was 100% in both groups. 17 women with SLNB prior to systemic treatment showed positive nodes (14 macrometastases and 3 micrometastases), and positive SLNB were detected in 15 women with SLNB after NAC, which were 14 macrometastases and 1 micrometastase. The negative predictive value of ultrasonography was 57.5% in patients with SLNB prior to neoadjuvant therapy and 78.9% in patients with chemotherapy followed by SLNB. Conclusions Intraoperative SLNB using OSNA in women with clinically negative axillary lymph nodes at initial presentation who received NAC could predict axillary status with high accuracy. Also it allows us to take decisions about the indication or not to perform an axillary dissection at the moment, thus avoiding delay in the administration of chemotherapy and benefiting the patients from a single surgical procedure. © 2013 Elsevier Ltd. All rights reserved.

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