IASOglio (fluoroethyl-L tyrosine (18F) or FET), radiopharmaceutical for diagnostic use for the detection of tumours

DIAGNOSTIC MEDICINAL PRODUCT - New medicinal product
Opinions on drugs - Posted on Nov 03 2016

Reason for request

Inclusion

No clinical benefit demonstrated by comparison with its comparators in the diagnosis of gliomas.

 

  • IASOglio has Marketing Authorisation in the diagnosis of gliomas by positron emission tomography (PET) imaging.
  • It allows characterisation of glioma-like brain lesions, biopsy guidance in the case of glioma-like brain lesions, grading of gliomas, definition of the limits of viable tumour tissue prior to radiotherapy and detection of viable tumour masses in cases of a suspected persistent or recurrent glioma.
  • No superiority has been shown relative to the comparators (brain MRI or PET with 18F‑fluorodopa).

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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