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IASOdopa®

6-[18F] Fluoro-L-3,4-dihydroxyphenylalanine

Therapeutic indications

This medicinal product is for diagnostic use only.

6-fluoro-(18F)-L-dopa is indicated for use with positron emission tomography (PET) in adults and paediatric population.

Neurology

PET with 6-fluoro-(18F)-L-dopa is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum. It can be used for diagnosis of Parkinson’s disease and differentiation between essential tremor and parkinsonian syndromes.

Oncology

Among medical imaging modalities, PET with 6-fluoro-(18F)-L-dopa provides a functional approach of pathologies, organs or tissues where enhanced intracellular transport and decarboxylation of the amino acid dihydroxyphenylalanine is the diagnostic target. The following indications have been particularly documented:

Diagnosis

  • Diagnosis and localisation of focal hyperplasia of beta islet cells in the case of hyperinsulinism in infants and children
  • Diagnosis and localisation of paragangliomas in patients with a gene mutation of the succinate dehydrogenase D variant
  • Localisation of pheochromocytoma

Staging

  • Phaeochromocytoma and paraganglioma
  • Well differentiated neuroendocrine tumours of midgut.

Detection in case of reasonable suspicion of recurrences or residual disease

  • Primary brain tumours of all grades of differentiation.
  • Phaeochromocytoma and paraganglioma
  • Medullary thyroid cancer with elevated serum levels of calcitonin
  • Well differentiated neuroendocrine tumours of midgut
  • Other endocrine digestive tumours when somatostatin receptor scintigraphy is negative

CLINICAL PARTICULARS

Approvals

Country Product Approval number Date of reg. PDF PDF
France IASOdopa 578 256-2 (15mL) 16.11.2006 SPC PIL
France IASOdopa 566 897-8 (25mL) 16.11.2006 SPC PIL
Germany IASOdopa 69747.00.00 04.08.2007 SPC PIL
Austria IASOdopa 4-00032 29.11.2007 SPC PIL
Italy Fluorodopa IASON 038449029 (15mL) 12.09.2013 SPC PIL
Italy Fluorodopa IASON 038449017 (25mL) 12.09.2013 SPC PIL
english IASOdopa   01.08.2007 SPC PIL
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