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AGuIX® from bench to bedside-Transfer of an ultrasmall theranostic gadolinium-based nanoparticle to clinical medicine.

ABSTRACT: AGuIX® are sub-5 nm nanoparticles made of a polysiloxane matrix and gadolinium chelates. This nanoparticle has been recently accepted in clinical trials in association with radiotherapy. This review will summarize the principal preclinical results that have led to first in man administration. No evidence of toxicity has been observed during regulatory toxicity tests on two animal species (rodents and monkeys). Biodistributions on different animal models have shown passive uptake in tumours due to enhanced permeability and retention effect combined with renal elimination of the nanoparticles after intravenous administration. High radiosensitizing effect has been observed with different types of irradiations in vitro and in vivo on a large number of cancer types (brain, lung, melanoma, head and neck…). The review concludes with the second generation of AGuIX nanoparticles and the first preliminary results on human.

SUBMITTER: Lux F

PROVIDER: S-EPMC6435081 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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AGuIX<sup>®</sup> from bench to bedside-Transfer of an ultrasmall theranostic gadolinium-based nanoparticle to clinical medicine.

Lux François F Tran Vu Long VL Thomas Eloïse E Dufort Sandrine S Rossetti Fabien F Martini Matteo M Truillet Charles C Doussineau Tristan T Bort Guillaume G Denat Franck F Boschetti Frédéric F Angelovski Goran G Detappe Alexandre A Crémillieux Yannick Y Mignet Nathalie N Doan Bich-Thuy BT Larrat Benoit B Meriaux Sébastien S Barbier Emmanuel E Roux Stéphane S Fries Peter P Müller Andreas A Abadjian Marie-Caline MC Anderson Carolyn C Canet-Soulas Emmanuelle E Bouziotis Penelope P Barberi-Heyob Muriel M Frochot Céline C Verry Camille C Balosso Jacques J Evans Michael M Sidi-Boumedine Jacqueline J Janier Marc M Butterworth Karl K McMahon Stephen S Prise Kevin K Aloy Marie-Thérèse MT Ardail Dominique D Rodriguez-Lafrasse Claire C Porcel Erika E Lacombe Sandrine S Berbeco Ross R Allouch Awatef A Perfettini Jean-Luc JL Chargari Cyrus C Deutsch Eric E Le Duc Géraldine G Tillement Olivier O

The British journal of radiology 20180918 1093

AGuIX<sup>®</sup> are sub-5 nm nanoparticles made of a polysiloxane matrix and gadolinium chelates. This nanoparticle has been recently accepted in clinical trials in association with radiotherapy. This review will summarize the principal preclinical results that have led to first in man administration. No evidence of toxicity has been observed during regulatory toxicity tests on two animal species (rodents and monkeys). Biodistributions on different animal models have shown passive uptake in tu ...[more]

PMID: 30226413

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Project description:BackgroundIn order to overcome the geometrical and physical limitations of conventional rotating and piezosurgery instruments used to perform bone osteotomies, as well as the difficulties in translating digital planning to the operating room, a stand-alone robot-guided laser system has been developed by Advanced Osteotomy Tools, a Swiss start-up company. We present our experiences of the first-in-man use of the Cold Ablation Robot-guided Laser Osteotome (CARLO®).MethodsThe CARLO® device employs a stand-alone 2.94-µm erbium-doped yttrium aluminum garnet (Er:YAG) laser mounted on a robotic arm. A 19-year-old patient provided informed consent to undergo bimaxillary orthognathic surgery. A linear Le Fort I midface osteotomy was digitally planned and transferred to the CARLO® device. The linear part of the Le Fort I osteotomy was performed autonomously by the CARLO® device under direct visual control. All pre-, intra-, and postoperative technical difficulties and safety issues were documented. Accuracy was analyzed by superimposing pre- and postoperative computed tomography images.ResultsThe CARLO® device performed the linear osteotomy without any technical or safety issues. There was a maximum difference of 0.8 mm between the planned and performed osteotomies, with a root-mean-square error of 1.0 mm. The patient showed normal postoperative healing with no complications.ConclusionThe newly developed stand-alone CARLO® device could be a useful alternative to conventional burs, drills, and piezosurgery instruments for performing osteotomies. However, the technical workflow concerning the positioning and fixation of the target marker and the implementation of active depth control still need to be improved. Further research to assess safety and accuracy is also necessary, especially at osteotomy sites where direct visual control is not possible. Finally, cost-effectiveness analysis comparing the use of the CARLO® device with gold-standard surgery protocols will help to define the role of the CARLO® device in the surgical landscape.

Project description:BackgroundIntervertebral disc nucleus degeneration initiates a degenerative cascade and can induce chronic low back pain. Nucleus replacement aims to replace the nucleus while the annulus is still intact. Over time, several designs have been introduced, but the definitive solution continues to be elusive. Therefore, we aimed to create a new nucleus replacement that replicates intact intervertebral disc biomechanics, and thus has the potential for clinical applications.Materials and methodsTwo implants with an outer ring and one (D2) with an additional midline strut were compared. Static and fatigue tests were performed with an INSTRON 8874 following the American Society for Testing and Materials F2267-04, F2346-05, 2077-03, D2990-01, and WK4863. Implant stiffness was analyzed at 0-300 N, 500-2000 N, and 2000-6000 N and implant compression at 300 N, 1000 N, 2000 N, and 6000 N. Wear tests were performed following ISO 18192-1:2008 and 18192-2:2010. GNU Octave software was used to calculate movement angles and parameters. The statistical analysis package R was used with the Deducer user interface. Statistically significant differences between the two designs were analyzed with ANOVA, followed by a post hoc analysis.ResultsD1 had better behavior in unconfined compression tests, while D2 showed a "jump." D2 deformed 1 mm more than D1. Sterilized implants were more rigid and deformed less. Both designs showed similar behavior under confined compression and when adding shear. A silicone annulus minimized differences between the designs. Wear under compression fatigue was negligible for D1 but permanent for D2. D1 suffered permanent height deformation but kept its width. D2 suffered less height loss than D1 but underwent a permanent width deformation. Both designs showed excellent responses to compression fatigue with no breaks, cracks, or delamination. At 10 million cycles, D2 showed 3-times higher wear than D1. D1 had better and more homogeneous behavior, and its wear was relatively low. It showed good mechanical endurance under dynamic loading conditions, with excellent response to axial compression fatigue loading without functional failure after long-term testing.ConclusionD1 performed better than D2. Further studies in cadaveric specimens, and eventually in a clinical setting, are recommended. Level of evidence 2c.

Dataset Information

AGuIX® from bench to bedside-Transfer of an ultrasmall theranostic gadolinium-based nanoparticle to clinical medicine.

Publications

AGuIX<sup>®</sup> from bench to bedside-Transfer of an ultrasmall theranostic gadolinium-based nanoparticle to clinical medicine.

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