FISABIO HOSPITAL UNIVERSITARIO DOCTOR PESET NUCLEAR MEDICINE

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HOSPITAL UNIVERSITARIO DOCTOR PESET HEAD OF RESEARCH SECTION ELISA CABALLERO CALABUIG CABALLERO_ELI@GVA.ES SAN LÁZARO, S/N, 1ª PLANTA / 46017 VALENCIA / SPAIN

The research activity of the Department of Nuclear Medicine revolves around three areas of ongoing research. AREA 1. Radioguided surgery by means of portable gamma cameras. These devices bring the information obtained by nuclear medicine techniques (molecular imaging) into the operating theatre. They provide functional information, and help surgeons locate lesions accurately (as they are usually very small and not easy to see with the naked eye) and verify that they have been fully resected. - Definition of surgical margins in nonpalpable breast cancer with a gamma detector probe and imaging obtained by a portable gamma camera of the lesion previously marked by means of a radiotracer. Analysing the reliability of this approach in the assessment of lesion margins after surgical resection in order to avoid late reinterventions due to positive margins. We compare this approach to current clinical practice, in which surgical margins are assessed by mammography of the resected specimen. Histology is used as the gold standard. - Minimally invasive surgery of the parathyroid. During parathyroid surgery, portable gamma cameras detect the abnormal parathyroid gland, which takes up an intravenous tumour tracer. Imaging of the lesion that is to be resected allows the surgeon to locate it, access it by means of a minimal incision, resect it and ascertain the absence of residual glands before completing the surgery. To date, the cure rate achieved in the case series we are analysing in our hospital has been similar to that achieved with bilateral cervical examination, with the advantages of minimally invasive surgery guided by metabolic imaging (it is quicker and safer, has fewer complications and better aesthetic results, and also reduces lengths of stay by at least one day). The goal of our current project is to determine in which cases intraoperative PTH (IO-PTH) monitoring, the current standard for determining surgical success, is not needed. - Sentinel lymph node detection in melanoma. Intraoperative imaging is particularly useful in cases of multiple or abnormal drainage, which are frequent when the primary tumour is localised to the head, neck or torso. We expect that intraoperative imaging will detect lesions in addition to those found in preoperative imaging, which would improve patient staging. AREA 2. Differentiated thyroid cancer. Improvement in the selection of patients for surgery by determination of thyroglobulin (Tg) levels in aspirate samples from cervical adenopathies following FNAB. This complements the information obtained by cytological testing. The goal is to better select patients with metastatic adenopathies for neck dissection, which requires knowing the lowest significant Tg value. We use histology as the gold standard, and ultrasound and clinical monitoring in non-surgical cases. AREA 3. Improving patient and patient contact safety as well as process efficiency. - Reducing the radiation exposure risk associated with nuclear medicine examinations by decreasing the administered activity and customising the recommendations regarding contact with individuals in the immediate environment of the patient. A necessary step is the quantification of the actual administered activity to adjust the prescribed activity to the activity recommended in the paediatric dosage card of the EANM and the Diagnostic Reference Levels (DRLs) of the EU. - Updating the current Nuclear Medicine software application (Calysap) with two objectives: improving its compatibility with electronic health records and including information on the dosimetry assessment of the patient for each of the examinations performed. FUNDACIÓN PARA EL FOMENTO DE LA INVESTIGACIÓN SANITARIA Y BIOMÉDICA DE LA COMUNIDAD VALENCIANA () / AVENIDA DE CATALUÑA, 21 / 46020 VALENCIA / SPAIN

OBJECTIVES The previously reviewed research areas pursue the following goals: OBJECTIVES ASSOCIATED WITH AREAS 1 AND 2 Introduction of techniques that improve patient selection and facilitate better surgical outcomes. This is the aim of using intraoperative radioguided imaging, both to expand the applications of minimally invasive surgery and to improve the yield of oncology procedures (accurate selection of tumours for surgical resection and in the detection and excision of sentinel lymph nodes). OBJECTIVES ASSOCIATED WITH AREA 3 03 To improve the safety of patients and personal contacts in their immediate environment, guaranteeing the lowest possible radiation risk derived from examinations or treatment with radioactive substances (radiopharmaceuticals). To improve process efficiency by implementing a custom-made software application, which should be linked to electronic health records, allowing complete tracking of nuclear medicine procedures, including the dosimetry assessment for each procedure performed in each patient. FUNDACIÓN PAR A EL FOMENTO DE L A INVESTIGACIÓN SANITARIA Y BIOMÉDIC A DE L A COMUNIDAD VALENCIANA () / AVENIDA DE C ATALUÑA, 21 / 46020 VALENCIA / SPAIN

AREAS OF RESEARCH AREA 1. Radioguided surgery using portable gamma radiography. 1A. DETERMINATION OF SURGICAL MARGINS IN NON-PALPABLE BREAST CAN- CER BY GAMMA DETECTION PROBE AND IMAGING OF LESION PREVIOUSLY MARKED WITH A RADIOTRACER OBTAINED BY PORTA- BLE GAMMA CAMERA (ROLL, RADIOGUIDED OCCULT LESION LOCALIZATION). - Specific goals: to reduce the frequency of late reinterventions due to positive surgical margins from incomplete tumour resections. from the nuclear medicine department (Drs Abreu, Reyes, Mut) and resident (MIR) physicians (Drs Rodríguez, Balaguer and Latorre). - Salient results: the preliminary results suggest that the use of radionuclide imaging combined with mammography improves the determination of surgical margins and has prevented future surgeries in three out of the forty patients studied to present. - Publications: best communication award at the Reunión de la Sociedad Valenciana de Medicina Nuclear 2014, project selected for an original article for the Revista Española de Medicina Nuclear (REMNIM), oral communication scheduled for the 2015 Annual Congress of the European Association of Nuclear Medicine (Hamburg). 1B. PORTABLE GAMMA CAMERAS IN PA- RATHYROID SURGERY - Specific goals: to be able to perform minimally invasive parathyroid surgery. To expand the use of radioguided surgery techniques to other surgical procedures. of the nuclear medicine department (Drs Abreu, Mut) and resident (MIR) physicians (Drs Rodríguez, Balaguer and Latorre). - Salient results: implementation of this approach to parathyroid surgery in our hospital, with more than 150 analysed cases. To present, the outcomes of this technique have not been inferior compared to the use of IO- PTH measurement. - Publications: communication in the 2014 Congress of the European Association of Nuclear Medicine (Gothenburg), doctoral dissertation of Dr Abreu (in progress). 1C. SENTINEL LYMPH NODE DETECTION IN PATIENTS WITH MELANOMA BY MEANS OF PORTABLE GAMMA CAMERAS - Specific goals: to demonstrate that intraoperative imaging using portable GCs detects a greater number of lymph nodes adjacent to the GC compared to conventional preoperative imaging, resulting in better patient staging. (Drs Abreu, Reyes, Mut) and resident (MIR ) physicians (Drs Rodríguez, Balaguer and Latorre) from the department. - Research project currently under development. AREA 2. Differentiated thyroid cancer. Improvement in patient selection for surgery. - Specific goals: due to its high PPV, elevation of Tg in FNAB specimens of cervical adenopathies in patients with differentiated thyroid cancer reinforces positive cytology findings. If cytology is negative, insufficient or inconclusive, an elevated Tg requires repeating the FNAB biopsy. At present, we are working toward determining the cut-off Tg value. - Participating staff: physicians from the nuclear medicine department (Drs Caballero, Reyes), radiopharmacy specialist (Dr Plancha) and resident (MIR) physicians (Drs Rodríguez, Balaguer and Latorre). 04 FUNDACIÓN PARA EL FOMENTO DE LA INVESTIGACIÓN SANITARIA Y BIOMÉDICA DE LA COMUNIDAD VALENCIANA () / AVENIDA DE CATALUÑA, 21 / 46020 VALENCIA / SPAIN

- Publications: oral communication at the 2013 Congreso Nacional de Medicina Nuclear and the European conference at Birmingham in 2014. AREA 3. Improving patient and patient contact safety and process efficiency. 3A. REDUCING RADIATION EXPOSURE RISKS ASSOCIATED WITH NUCLEAR MEDICI- NE EXAMINATIONS - Participating staff: radiopharmacist (Dr Plancha) and physicians (Drs Caballero and Reyes). In collaboration with the Department of Radiation Safety of the Hospital Dr. Peset. - Salient results: our preliminary results show a mean reduction in the injected radioactivity of more than 30% in paediatric patients. 3B. IMPROVING PROCESS EFFICIENCY - Specific goals: include data on the dosimetric assessment for each patient and each examination that uses radiopharmaceuticals in the existing software application. Achieve direct dumping of these data into electronic health records. - Participating staff: physician (Dr Caballero), radiopharmacist (Dr Plancha). In collaboration with the Departments of Radiation Safety and Information Technology of the Hospital Doctor Peset. - Salient results: we are already obtaining dosimetry data for 20% of the patients, which is recorded in the database of the department s application (Calysap). A dosimetry card is provided to 99% of patients that undergo metabolic radiotherapy. - Publications: the reduction of injected radioactivity is the subject of the doctoral dissertation of Dr Plancha. RESEARCH GROUP RESEARCH GROUP COORDINATOR ELISA CABALLERO CALABUIG CHIEF OF THE DEPARTMENT OF CABALLERO_ELI@GVA.ES T. +34 961622404 GROUP MEMBERS Mª DOLORES REYES OJEDA REYES_DOL@GVA.ES PEDRO ABREU SÁNCHEZ ABREU_PED@GVA.ES TOMÁS MUT DÓLERA TOMASMUT@HOTMAIL.COM Mª CARMEN PLANCHA MANSANET PLANCHA_MCA@GVA.ES HÉCTOR RODRÍGUEZ PARRA TTICOR@HOTMAIL.COM DAVID BALAGUER MUÑOZ DAVIDALBALAT@HOTMAIL.COM IRENE LATORRE AGRAZ LAIRENE_9@HOTMAIL.COM FOR MORE INFORMATION ON S ACTIVITIES AND SERVICES: WWW..SAN.GVA.ES / T. +34 961925700 / M. @GVA.ES 05 FUNDACIÓN PARA EL FOMENTO DE LA INVESTIGACIÓN SANITARIA Y BIOMÉDICA DE LA COMUNIDAD VALENCIANA () / AVENIDA DE CATALUÑA, 21 / 46020 VALENCIA / SPAIN THE ELABORATION OF THIS DOCUMENT HAS BEEN FUNDED BY THE PROJECT AFI-01/14, IN THE CONTEXT OF THE GRANTS FOR PARTICIPATION IN EUROPEAN COMMISSION RESEARCH PROGRAMMES ON HEALTH GIVEN BY THE CONSELLERIA DE SANITAT UNIVERSAL I SALUT PÚBLICA OF THE GOVERNMENT OF VALENCIA FOR THE 2014-2015 FISCAL PERIOD.