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Quality assurance guidelines for superficial hyperthermia clinical trials : II. Technical requirements for heating devices.

ABSTRACT: Quality assurance (QA) guidelines are essential to provide uniform execution of clinical trials with uniform quality hyperthermia treatments. This document outlines the requirements for appropriate QA of all current superficial heating equipment including electromagnetic (radiative and capacitive), ultrasound, and infrared heating techniques. Detailed instructions are provided how to characterize and document the performance of these hyperthermia applicators in order to apply reproducible hyperthermia treatments of uniform high quality. Earlier documents used specific absorption rate (SAR) to define and characterize applicator performance. In these QA guidelines, temperature rise is the leading parameter for characterization of applicator performance. The intention of this approach is that characterization can be achieved with affordable equipment and easy-to-implement procedures. These characteristics are essential to establish for each individual applicator the specific maximum size and depth of tumors that can be heated adequately. The guidelines in this document are supplemented with a second set of guidelines focusing on the clinical application. Both sets of guidelines were developed by the European Society for Hyperthermic Oncology (ESHO) Technical Committee with participation of senior Society of Thermal Medicine (STM) members and members of the Atzelsberg Circle.

SUBMITTER: Dobsicek Trefna H

PROVIDER: S-EPMC5405104 | biostudies-other | 2017 May

REPOSITORIES: biostudies-other

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Quality assurance guidelines for superficial hyperthermia clinical trials : II. Technical requirements for heating devices.

Dobšíček Trefná Hana H Crezee Johannes J Schmidt Manfred M Marder Dietmar D Lamprecht Ulf U Ehmann Michael M Nadobny Jacek J Hartmann Josefin J Lomax Nicolleta N Abdel-Rahman Sultan S Curto Sergio S Bakker Akke A Hurwitz Mark D MD Diederich Chris J CJ Stauffer Paul R PR Van Rhoon Gerard C GC

Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] 20170301 5

Quality assurance (QA) guidelines are essential to provide uniform execution of clinical trials with uniform quality hyperthermia treatments. This document outlines the requirements for appropriate QA of all current superficial heating equipment including electromagnetic (radiative and capacitive), ultrasound, and infrared heating techniques. Detailed instructions are provided how to characterize and document the performance of these hyperthermia applicators in order to apply reproducible hypert ...[more]

PMID: 28251250

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Project description:Despite its promising therapeutic potential, nanoparticle-mediated magnetic hyperthermia is currently limited to the treatment of localized and relatively accessible cancer tumors because the required therapeutic temperatures above 40 °C can only be achieved by direct intratumoral injection of conventional iron oxide nanoparticles. To realize the true potential of magnetic hyperthermia for cancer treatment, there is an unmet need for nanoparticles with high heating capacity that can efficiently accumulate at tumor sites following systemic administration and generate desirable intratumoral temperatures upon exposure to an alternating magnetic field (AMF). Although there have been many attempts to develop the desired nanoparticles, reported animal studies reveal the challenges associated with reaching therapeutically relevant intratumoral temperatures following systemic administration at clinically relevant doses. Therefore, we developed efficient magnetic nanoclusters with enhanced heating efficiency for systemically delivered magnetic hyperthermia that are composed of cobalt- and manganese-doped, hexagon-shaped iron oxide nanoparticles (CoMn-IONP) encapsulated in biocompatible PEG-PCL (poly(ethylene glycol)- b-poly(ε-caprolactone))-based nanocarriers. Animal studies validated that the developed nanoclusters are nontoxic, efficiently accumulate in ovarian cancer tumors following a single intravenous injection, and elevate intratumoral temperature up to 44 °C upon exposure to safe and tolerable AMF. Moreover, the obtained results confirmed the efficiency of the nanoclusters to generate the required intratumoral temperature after repeated injections and demonstrated that nanocluster-mediated magnetic hyperthermia significantly inhibits cancer growth. In summary, this nanoplatform is a milestone in the development of systemically delivered magnetic hyperthermia for the treatment of cancer tumors that are difficult to access for intratumoral injection.

Project description:INTRODUCTION:Adverse event (AE) under-reporting has been a recurrent issue raised during health authorities Good Clinical Practices (GCP) inspections and audits. Moreover, safety under-reporting poses a risk to patient safety and data integrity. The current clinical Quality Assurance (QA) practices used to detect AE under-reporting rely heavily on investigator site and study audits. Yet several sponsors and institutions have had repeated findings related to safety reporting, and this has led to delays in regulatory submissions. Recent developments in data management and IT systems allow data scientists to apply techniques such as machine learning to detect AE under-reporting in an automated fashion. OBJECTIVE:In this project, we developed a predictive model that enables Roche/Genentech Quality Program Leads oversight of AE reporting at the program, study, site, and patient level. This project was part of a broader effort at Roche/Genentech Product Development Quality to apply advanced analytics to augment and complement traditional clinical QA approaches. METHOD:We used a curated data set from 104 completed Roche/Genentech sponsored clinical studies to train a machine learning model to predict the expected number of AEs. Our final model used 54 features built on patient (e.g., demographics, vitals) and study attributes (e.g., molecule class, disease area). RESULTS:In order to evaluate model performance, we tested how well it would detect simulated test cases based on data not used for model training. For relevant simulation scenarios of 25%, 50%, and 75% under-reporting on the site level, our model scored an area under the curve (AUC) of the receiver operating characteristic (ROC) curve of 0.62, 0.79, and 0.92, respectively. CONCLUSION:The model has been deployed to evaluate safety reporting performance in a set of ongoing studies in the form of a QA/dashboard cockpit available to Roche Quality Program Leads. Applicability and production performance will be assessed over the next 12-24 months in which we will develop a validation strategy to fully integrate our model into Roche QA processes.

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Quality assurance guidelines for superficial hyperthermia clinical trials : II. Technical requirements for heating devices.

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Quality assurance guidelines for superficial hyperthermia clinical trials : II. Technical requirements for heating devices.

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