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PURPOSE: The clinical introduction of the hybrid tracer indocyanine green (ICG)-(99m)Tc-nanocolloid, composed of a radioactive and a near-infrared (NIR) fluorescence component, has created the need for surgical (imaging) modalities that allow for simultaneous detection of both signals. This study describes the first-in-human use of a prototype opto-nuclear probe during sentinel node (SN) biopsy using ICG-(99m)Tc-nanocolloid. METHODS: To allow for fluorescence tracing, a derivative of the conventional gamma probe technology was generated in which two optical fibers were integrated to allow for excitation (785 nm) and emission signal collection (> 810 nm). The ability of this opto-nuclear probe to detect the fluorescence signal of the hybrid tracer ICG-(99m)Tc-nanocolloid was firstly determined ex vivo in (non)SNs samples obtained from 41 patients who underwent hybrid tracer-based SN biopsy in the head and neck or urogenital area. In an in vivo proof-of-concept study in nine of these 41 patients, SNs were localized using combined gamma and fluorescence tracing with the opto-nuclear probe. Fluorescence tracing was performed in a similar manner as gamma tracing and under ambient light conditions. RESULTS: Ex vivo, the gamma tracing option of the opto-nuclear probe correctly identified the SN in all 150 evaluated (non)SN samples. Ex vivo fluorescence tracing in the low-sensitivity mode correctly identified 71.7% of the samples. This increased to 98.9% when fluorescence tracing was performed in the high-sensitivity mode. In vivo fluorescence tracing (high-sensitivity mode) accurately identified the SNs in all nine patients (20 SNs evaluated; 100%). CONCLUSION: This study demonstrates the first-in-human evaluation of a hybrid modality capable of detecting both gamma and fluorescence signals during a surgical procedure. Fluorescence tracing could be performed in ambient light.
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Corantes Fluorescentes/química , Verde de Indocianina/química , Raios Infravermelhos , Cirurgia Assistida por Computador/métodos , Agregado de Albumina Marcado com Tecnécio Tc 99m/química , Idoso , Feminino , Humanos , Período Intraoperatório , Masculino , Pessoa de Meia-Idade , Fibras Ópticas , Imagens de Fantasmas , Traçadores Radioativos , Biópsia de Linfonodo Sentinela , Cirurgia Assistida por Computador/instrumentaçãoRESUMO
BACKGROUND: Intraoperative sentinel node (SN) identification in patients with head-and-neck malignancies can be challenging due to unexpected drainage patterns and anatomical complexity. Here, intraoperative navigation-based guidance technologies may provide outcome. In this study, gamma camera-based freehandSPECT was evaluated in combination with the hybrid tracer ICG-99mTc-nanocolloid. MATERIALS AND METHODS: Eight patients with melanoma located in the head-and-neck area were included. Indocyanine green (ICG)-99mTc-nanocolloid was injected preoperatively, whereafter lymphoscintigraphy and SPECT/CT imaging were performed in order to define the location of the SN(s). FreehandSPECT scans were generated in the operation room using a portable gamma camera. For lesion localization during surgery, freehandSPECT scans were projected in an augmented reality video-view that was used to spatially position a gamma-ray detection probe. Intraoperative fluorescence imaging was used to confirm the accuracy of the navigation-based approach and identify the exact location of the SNs. RESULTS: Preoperatively, 15 SNs were identified, of which 14 were identified using freehandSPECT. Navigation towards these nodes using the freehandSPECT approach was successful in 13 nodes. Fluorescence imaging provided optical confirmation of the navigation accuracy in all patients. In addition, fluorescence imaging allowed for the identification of (clustered) SNs that could not be identified based on navigation alone. CONCLUSIONS: The use of gamma camera-based freehandSPECT aids intraoperative lesion identification and, with that, supports the transition from pre- to intraoperative imaging via augmented reality display and directional guidance.
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OBJECTIVE: To explore the feasibility of an intraoperative navigation technology based on preoperatively acquired single photon emission computed tomography combined with computed tomography (SPECT/CT) images during sentinel node (SN) biopsy in patients with melanoma or Merkel cell carcinoma. MATERIALS AND METHODS: Patients with a melanoma (n=4) or Merkel cell carcinoma (n=1) of a lower extremity scheduled for wide re-excision of the primary lesion site and SN biopsy were studied. Following a Tc-nanocolloid injection and lymphoscintigraphy, SPECT/CT images were acquired with a reference target (ReTp) fixed on the leg or the iliac spine. Intraoperatively, a sterile ReTp was placed at the same site to enable SPECT/CT-based mixed-reality navigation of a gamma ray detection probe also containing a reference target (ReTgp).The accuracy of the navigation procedure was determined in the coronal plane (x, y-axis) by measuring the discrepancy between standard gamma probe-based SN localization and mixed-reality-based navigation to the SN. To determine the depth accuracy (z-axis), the depth estimation provided by the navigation system was compared to the skin surface-to-node distance measured in the computed tomography component of the SPECT/CT images. RESULTS: In four of five patients, it was possible to navigate towards the preoperatively defined SN. The average navigational error was 8.0 mm in the sagittal direction and 8.5 mm in the coronal direction. Intraoperative sterile ReTp positioning and tissue movement during surgery exerted a distinct influence on the accuracy of navigation. CONCLUSION: Intraoperative navigation during melanoma or Merkel cell carcinoma surgery is feasible and can provide the surgeon with an interactive 3D roadmap towards the SN or SNs in the groin. However, further technical optimization of the modality is required before this technology can become routine practice.
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Carcinoma de Célula de Merkel/patologia , Biópsia Guiada por Imagem/métodos , Melanoma/patologia , Biópsia de Linfonodo Sentinela/métodos , Linfonodo Sentinela/patologia , Neoplasias Cutâneas/patologia , Adulto , Idoso , Carcinoma de Célula de Merkel/diagnóstico por imagem , Carcinoma de Célula de Merkel/cirurgia , Estudos de Viabilidade , Feminino , Humanos , Extremidade Inferior/diagnóstico por imagem , Extremidade Inferior/patologia , Masculino , Melanoma/diagnóstico por imagem , Melanoma/cirurgia , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Linfonodo Sentinela/diagnóstico por imagem , Linfonodo Sentinela/cirurgia , Neoplasias Cutâneas/diagnóstico por imagem , Neoplasias Cutâneas/cirurgia , Interface Usuário-ComputadorRESUMO
PURPOSE: Even when guided by SPECT/CT planning of nodal resection in the head-and-neck area is challenging due to the many critical anatomical structures present within the surgical field. In this study the potential of a (SPECT/)MRI-based surgical planning method was explored. Hereby MRI increases the identification of SNs within clustered lymph nodes (LNs) and vital structures located adjacent to the SN (such as cranial nerve branches). METHOD AND PATIENTS: SPECT/CT and pathology reports from 100 head-and-neck melanoma and 40 oral cavity cancer patients were retrospectively assessed for SN locations in levels I-V and degree of nodal clustering. A diffusion-weighted-preparation magnetic resonance neurography (MRN) sequence was used in eight healthy volunteers to detect LNs and peripheral nerves. RESULTS: In 15% of patients clustered nodes were retrospectively shown to be present at the location where the SN was identified on SPECT/CT (level IIA: 37.2%, level IIB: 21.6% and level III: 15.5%). With MRN, improved LN delineation enabled discrimination of individual LNs within a cluster. Uniquely, this MRI technology also provided insight in LN distribution (23.2±4 LNs per subject) and size (range 21-372mm(3)), and enabled non-invasive assessment of anatomical variances in the location of the LNs and facial nerves. CONCLUSION: Diffusion-weighted-preparation MRN enabled improved delineation of LNs and their surrounding delicate anatomical structures in the areas that most often harbor SNs in the head-and-neck. Based on our findings a combined SPECT/MRI approach is envisioned for future surgical planning of complex SN resections in this region.
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Imagem de Difusão por Ressonância Magnética/métodos , Neoplasias de Cabeça e Pescoço/patologia , Excisão de Linfonodo/métodos , Voluntários Saudáveis , Humanos , Imagem Multimodal , Estudos Retrospectivos , Biópsia de Linfonodo Sentinela , Tomografia Computadorizada de Emissão de Fóton Único , Tomografia Computadorizada por Raios XRESUMO
Accurate pre- and intraoperative identification of the sentinel node (SN) forms the basis of the SN biopsy procedure. Gamma tracing technologies such as a gamma probe (GP), a 2D mobile gamma camera (MGC) or 3D freehandSPECT (FHS) can be used to provide the surgeon with radioguidance to the SN(s). We reasoned that integrated use of these technologies results in the generation of a "hybrid" modality that combines the best that the individual radioguidance technologies have to offer. The sensitivity and resolvability of both 2D-MGC and 3D-FHS-MGC were studied in a phantom setup (at various source-detector depths and using varying injection site-to-SN distances), and in ten breast cancer patients scheduled for SN biopsy. Acquired 3D-FHS-MGC images were overlaid with the position of the phantom/patient. This augmented-reality overview image was then used for navigation to the hotspot/SN in virtual-reality using the GP. Obtained results were compared to conventional gamma camera lymphoscintigrams. Resolution of 3D-FHS-MGC allowed identification of the SNs at a minimum injection site (100 MBq)-to-node (1 MBq; 1%) distance of 20 mm, up to a source-detector depth of 36 mm in 2D-MGC and up to 24 mm in 3D-FHS-MGC. A clinically relevant dose of approximately 1 MBq was clearly detectable up to a depth of 60 mm in 2D-MGC and 48 mm in 3D-FHS-MGC. In all ten patients at least one SN was visualized on the lymphoscintigrams with a total of 12 SNs visualized. 3D-FHS-MGC identified 11 of 12 SNs and allowed navigation to all these visualized SNs; in one patient with two axillary SNs located closely to each other (11 mm), 3D-FHS-MGC was not able to distinguish the two SNs. In conclusion, high sensitivity detection of SNs at an injection site-to-node distance of 20 mm-and-up was possible using 3D-FHS-MGC. In patients, 3D-FHS-MGC showed highly reproducible images as compared to the conventional lymphoscintigrams.