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IASOtoc

Gallium (68Ga) edotreotide

Therapeutic indications

This medicinal product is for diagnostic use only.

IASOtoc binds specifically to somatostatin receptors.

IASOtoc is indicated for use with positron emission tomography (PET).

IASOtoc is used for imaging in patients undergoing oncologic diagnostic procedures describing functions or diseases where enhanced somatostatin receptors expression of specific organs or tissues is the diagnostic target.

The following indications have been particularly documented:

  • detection of the primary occult neuroendocrine tumour when a metastasis of neuroendocrine tumour has been demonstrated or when the serum concentration of a specific marker is increased,
  • characterisation of bronchial mass as neuroendocrine tumour when other diagnostic modalities have not been conclusive,
  • characterisation, initial staging, detection in case of biochemical recurrence and restaging of neuroendocrine tumours of the foregut, including in the thymus or the bronchi,
  • characterisation, initial staging, detection in case of biochemical recurrence and restaging of neuroendocrine tumours of the midgut, when 6-fluoro-(18F)-L-dihydroxyphenylalanine is not available or when PET with 6-fluoro-(18F)-L-dihydroxyphenylalanine is non-conclusive,
  • as an adjunct to anatomic imaging in pre-therapeutic evaluation of meningeoma.

Tumours which do not bear somatostatin receptors will not be visualised with IASOtoc.

CLINICAL PARTICULARS

Approvals

Country Product Approval number Date of registration PDF PDF
Austria IASOtoc 20 MBq/mL, Injektionslösung 437334 07.12.2016 SPC PIL
France IASOtoc 20 MBq/mL, solution injectable 34009 550 236 9 2 01.07.2016 SPC PIL
Germany IASOtoc 20 MBq/ml Injektionslösung 98351.00.00 09.12.2016 SPC PIL
english IASOtoc 20 MBq/mL, solution for injection n.a. 05.12.2016 SPC PIL
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