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ESR/EORTC - Imaging biomarker and education for multicentre clinical oncological trials

Thursday, March 2, 16:00 - 17:30 Room: X Session Type: Joint Session of the ESR and EORTC Topics: Evidence-Based Imaging, Oncologic Imaging Moderators: N. M. deSouza (Sutton/UK), Y. Liu (Brussels/BE) Add session to my schedule In your schedule (remove)

A-296

Imaging as primary endpoint in clinical trials: perspective of the EORTC

Y. Liu; Brussels/BE

Learning Objectives

1. To become familiar with the importance of imaging biomarker in oncologic trials.
2. To learn about the role of the Imaging group of the EORTC.
3. To appreciate how standardisation and quality assessment enhances the role of imaging in oncologic trials.

Abstract

Imaging biomarkers have evolved in clinical trials, thanks to improvements in conventional imaging and innovation in advanced imaging techniques. Imaging biomarkers play key roles as outcome measures in trials, and are also used for patient selection, stratification, and safety monitoring tools (measure harm or lack of harm related to treatment). Despite the obvious values of imaging, the integration of imaging biomarkers into trials faces various challenges, such as the complexity of imaging techniques, lack of standardization across multivendor platforms, and paucity of optimized trial design and operational support. Those pitfalls become more apparent, especially in centers with little experience in clinical trials that involve imaging. A risk management approach will be introduced in the presentation, to manage trials with imaging endpoints. It could be a useful tool for prioritization, and avoid undue cost and eventually decreases trial attrition rate. An initial risk assessment plan should be performed before study initiation, which might be achieved with a multidisciplinary team, including imaging experts, clinicians, and study project managers. The risk plan should also be reviewed and updated throughout the trial, to ensure that actions have been or will be taken. This session will set the scene for discussion with imaging experts, to improve the implementation and utilization of imaging biomarkers within clinical trials.

A-297

Imaging biomarker for clinical trials in brain tumours

M. Smits; Rotterdam/NL

Learning Objectives

1. To consolidate knowledge about state-of-the-art quantitative MRI.
2. To learn about standardisation and validation.
3. To appreciate the value of quantitative MRI in tumour grading and therapy response.

Abstract

Gliomas are the most common primary brain tumours and constitute a group of tumours with heterogeneous clinical behaviour, with many therapeutic agents under investigation for their effectiveness. The assessment of treatment effect is, however, not without difficulty. It is on the one hand hampered by therapy-related changes which can be indistinguishable from tumour progression, such as pseudoprogression or radiation necrosis, and on the other hand by a phenomenon called pseudoresponse, occurring in the context of anti-angiogenic treatment, in which contrast enhancement diminishes unrelated to an actual anti-tumoural effect. New, preferably quantitative, markers of response are desperately needed to assess treatment response as accurately and early as possible within the context of a clinical trial. Furthermore, recent insights indicate that the clinical heterogeneity of glioma behaviour can - at least in part - be attributed to the tumour genotype. In the context of clinical trials, it is adamant that patients are correctly stratified according to their tumour genotype, which at this point in time can only be determined from tumour tissue acquired through biopsy/surgery. To avoid such invasive procedures, as well as to obtain a full overview of the tumour and its heterogeneity, and to be able to follow changes over time, imaging can play an important role using a radiogenomic approach. In this presentation, I will discuss the current and potential imaging markers of glioma biological behaviour and response to treatment, and the challenges for implementation in clinical, multicentre trials.

A-298

The importance of collaboration between the European Initiative on Biomarkers Alliance (EIBALL) and EORTC

S. Trattnig; Vienna/AT

Learning Objectives

1. To become familiar with recent developments of collaboration between EIBALL and EORTC.
2. To learn about the increasing role of radiologists in oncologic trials.
3. To appreciate the importance of imaging biomarker in multicentre trials.

Abstract

EORTC performs many clinical multicentre trials per year, has 150,000 patients in its database, with 50,000 in the follow-up stage, and comprises 2000 collaborators. Organizationally, EORTC is subdivided into 18 disease-oriented groups with their own respective steering committees in which multicentre trials are planned and performed. The imaging group (comprising radiologists, nuclear medical physicians, physicists and imaging scientists) is part of the "Translational Research and Imaging Department“ within EORTC, and is responsible for imaging protocols in multicentre trials, in collaboration with the disease-specific groups and their steering committees in EORTC. The role of EIBALL is to strengthen the collaboration with the imaging group of EORTC with the integration of more radiologists into the imaging group. There is also a need to integrate more imaging people, particularly radiologists, into the disease-oriented groups and their respective steering committees of EORTC where multicentre studies are developed and to which imaging protocols can be implemented. This will allow clinical validation of different imaging biomarkers in multicentre trials. Imaging protocols, including quantitative imaging biomarkers, should be proposed and distributed to the members of EIBALL, and an expert consensus should be achieved, which then should be integrated within the EORTC multicentre studies. Imaging protocols that are acceptable for a number of sites should be established and a program of quality assurance/quality control should be implemented prior to imaging in multicentre trials. In planned multicentre projects, potential sites should be recruited based on a site qualification process for clinical validation of imaging biomarkers.

A-299

Training possibilities for radiologists involved in clinical multicentre trials

L. S. Fournier; Paris/FR

Learning Objectives

1. To become familiar with education of radiologists for oncologic trials.
2. To learn about the advantages of education for implementation and evaluation of clinical trials.
3. To appreciate the value of educational courses on clinical multicentre trials for radiologists.

Abstract

In most oncological clinical trials, imaging is now the primary criteria to evaluate progression of disease or efficiency of the drug being tested. But the quality of radiological data extracted from clinical trials remains unequal, partly because of lack of familiarity of radiologists with requisites for clinical trials. There are very few international training possibilities specifically for radiologists involved in clinical multicentre trails. Lack of proper training for radiologists or radiographers is one of main reasons that cause quality problems and errors, because protocols are not properly introduced at the start of the trial. Imagers may not adapt their parameters according to what is being studied, nor may they include the necessary quantitative measurements in their reports. Radiologists must be trained to use the appropriate protocols for an on-going trial and to evaluate data according to international criteria, because these criteria are specialised. Clinicians, for their part, must be educated on the implications of using imaging data in their trials and they must be aware of the importance of quality control of these measurements, which only imagers can do. Patients are included and treatment discontinued based on local readings of images before it is evaluated by an independent central reading. ESR and EORTC need to be actively involved in developing training opportunities for radiologists to learn the importance of imaging-derived data in clinical trials.

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