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EIBIR 2 - MITIGATE: What does it take to perform clinical trials in interventional radiology?

Friday, March 4, 14:00 - 15:30 Room: L8 Session Type: EIBIR Session Topics: Interventional Radiology, Management Add session to my schedule In your schedule (remove)

A-411 14:00

Introduction (part 1)

S.O. Schönberg;  Mannheim/DE
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Learning Objectives

1. To introduce the aims of the session.
2. To highlight the importance of clinical trials in interventional radiology.
3. To introduce the related objectives of the MITIGATE project.

Abstract

The session aims at presenting an overview of the clinical trials in interventional radiology in Europe. A member of the Scientific Programme Committee of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) will present the overall situation and challenges ahead. Two successful case examples of respective investigator initiated and industry co-sponsored trials will be introduced. Finally the concept of a clinical trial in oligometastatic GIST, which will start in mid 2016, will be presented by a partner of the MITIGATE consortium. MITIGATE is an FP7 co-funded project that aims at developing new protocols and guidelines to effectively diagnose and treat patients with metastatic GIST resistant to current treatment.

A-412 14:05

Introduction (part 2)

W.R. Jaschke;  Innsbruck/AT

Learning Objectives

1. To introduce the aims of the session.
2. To highlight the importance of clinical trials in interventional radiology.
3. To introduce the related objectives of the MITIGATE project.

Abstract

Many advancements in clinical medicine are related to results obtained from randomized clinical trials. For example, modern pharmacotherapy is based on a standardized approach for discovery, development and testing of new pharmacological agents. On the contrary, many surgical and interventional procedures were introduced into clinical medicine without performing clinical trials. Nevertheless, it is common sense in modern medicine that diagnosis and treatment of medical conditions should be based on science, not on speculation or individual experience. The proof of principle has, therefore, to be supplemented by scientific data. If a retrospective comparison between surgery and interventional radiology reveals a non-inferiority of the interventional procedure or potential improvement of patient care (example: treatment of non- surgical candidates), the interventional procedure obtains wider acceptance. This is usually the starting point for conducting a controlled clinical trial. A controlled clinical trial should ultimately help to decide which therapy results in the best outcome. A typical example is the introduction of carotid artery stenting. The proof of principle was that this procedure can be performed safely without an increase of disabling complications. The procedure gained wide acceptance with a dramatic increase of the number of procedures performed worldwide. Controlled clinical trials showed, however, that older patients who usually suffer more from operative trauma do not benefit from the percutaneous approach. But the controlled trials indicated also that for all other patients carotid artery stenting offers comparable results to surgery and is, therefore, an attractive alternative to surgery.

A-413 14:10

Overview on clinical trials in interventional radiology in Europe

A. Gangi;  Strasbourg/FR

Learning Objectives

1. To learn about the European framework for clinical trials in interventional radiology.
2 To learn about the requirements for clinical trials in interventional radiology in Europe.
3. To learn about successfully conducted clinical trials in interventional radiology.

Abstract

"no abstract submitted"

A-414 14:30

How to implement investigator-initiated or industry-sponsored trials in interventional oncology: SORAMIC vs SIRFLOX

J. Ricke1, W. Richter2;  1Magdeburg/DE, 2Berlin/DE

Learning Objectives

1. To learn about two examples of clinical trials in interventional oncology.
2. To learn about the implementation of clinical trials in interventional oncology.
3. To learn more about industry involvement in clinical trials in interventional oncology.

Abstract

"no abstract submitted"

A-415 14:50

Design of a clinical trial in oligometastatic GIST: results from the MITIGATE consortium

C. Decristoforo;  Innsbruck/AT

Learning Objectives

1. To learn about the aims of the clinical trial performed in the MITIGATE project.
2. To learn about the design of a clinical trial in oligometastatic GIST.
3. To learn about the expected impact of the clinical trial.

Abstract

Within the MITIGATE project (Closed-loop Molecular Environment for Minimally Invasive Treatment of Patients with Metastatic Gastrointestinal Stromal Tumours, EU-FP7, grant agreement no 602306) a clinical trial in patients with therapy-resistant GIST will be initiated in 2016. A novel radiopharmaceutical for PET/CT targeting GIST tumours, developed and characterized within the MITIGATE project will be applied for tumour visualisation and characterization. This presentation will describe the requirements to bring a novel radiotracer into the clinical application focussing on the pharmaceutical standards (GMP), the design of a first-in-human application meeting Good Clinical Practices (GCP) and the European regulatory environment involved. Primary objectives of the trial will be safety and pharmacokinetics, but it aims also to provide a basis for better characterization of GIST tumours by molecular imaging opening new therapeutic options in this rare disease.

15:10

Discussion

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no recording
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