Neuroendocrine Tumors Clinical Trial
Official title:
Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors: a First-in-human PET/CT Study
The aim of this study is to evaluate the potential of Al18F-1,4,7-triazacyclononane-1,4,7-triacetate-octreotide (Al18F-NOTA-octreotide) as a positron emission tomography (PET) somatostatin receptor imaging agent in patients with neuroendocrine tumors.
In the first part of the study, six healthy volunteers will undergo several sequential
whole-body PET/CT scans starting from the moment of tracer injection up to six hours post
injection for an initial safety assessment and dosimetry study of Al18F-NOTA-octreotide in
humans.
In the second part of the study, six neuroendocrine tumor patients, with at least five
positive lesions on routine clinical 68Ga-DOTA-peptide PET, will undergo a dynamic PET scan
for the first 45 minutes, followed by three single static whole-body PET/CTs up to three
hours post injection for an initial efficacy assessment (evaluation of the lesion detection
rate) and pharmacokinetics study of Al18F-NOTA-octreotide in humans. Furthermore a first
comparison with 68Ga-DOTA peptide PET will be performed.
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