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SEVENTH FRAMEWORK PROGRAMME

WP 04 - Clinical Assessment

1. Objectives

  1. Preparation and assessment of clinical grade PET/SPECT beta-cell tracer candidates will be performed.
  2. PET/SPECT scanning methods and protocols for quantitation of beta-cell mass will be developed.
  3. Clinical imaging studies will be implemented with the aim of providing proof-of-principle for non-invasive imaging of beta-cell mass in humans.

2. Description

Diabetes mellitus (diabetes) is caused by a relative deficiency of insulin resulting from loss of insulin-producing beta-cells in the pancreas (type 1 and advanced type 2 diabetes) or from peripheral insulin resistance (type 2 diabetes). Because of compensatory insulin secretion by remaining beta-cells, deterioration of blood glucose homeostasis may not be evident until a major portion of the beta-cells have already been destroyed. At present, there is no accurate method available for the assessment of beta-cell mass in the living human. PET (positron emission tomography) and SPECT (single photon emission computed tomography) are sensitive, non-invasive, and quantitative molecular imaging tools, which are already being used clinically to detect pancreatic tumours (Figure 1). With the development of suitable beta-cell-specific PET and SPECT tracers, quantitative imaging of normal pancreatic beta-cells may also become possible. The successful development of imaging tools for beta-cell mass in humans is expected to provide new insights into the pathophysiology of diabetes and to aid in the development of new therapeutic strategies.

Beta-cell hyperplasia in pancreas (18F-DOPA PET)

Figure 1. Beta-cell hyperplasia (arrow) in the head of the pancreas of a 34-year-old woman imaged by 18F-DOPA PET (Kauhanen et al. (2007) J Clin Endocrinol Metab 92:1237-1244).

Within WP 04, new beta-cell tracer candidates, developed within the BetaImage consortium, will be subjected to clinical testing. The process involves the preparation and assessment of clinical grade PET/SPECT tracers, including toxicity testing, the development of PET/SPECT scanning protocols for quantitative imaging of beta-cell mass and its loss, and clinical imaging studies in healthy volunteers and patients with type 1 and type 2 diabetes. WP 04 also coordinates the operations and activities related to ethical issues associated with studies involving human subjects.

3. WP Leader

WP leader is Prof. Pirjo Nuutila - University of Turku, Finland


4. WP partners

Radboud University Nijmegen, The Netherlands
Université Libre de Bruxelles, Belgium
University Hospital Freiburg, Germany

 

 

 

 

 

Clinical Assessment