Loading
SomaKit TOC is a kit used to make a radioactive tracer for a PET scan in adults known or thought to have a neuroendocrine tumour of the gut or pancreas. The tracer sticks to the tumour cells so the scan can show where the tumour started and where it has spread.
SomaKit TOC (edotreotide; marketing authorisation holder Novartis Europharm Limited) has been authorised in the EU since 8 December 2016 (CHMP opinion 15 September 2016) and was designated an orphan medicine on 19 March 2015. It is for diagnostic use only: after radiolabelling with gallium (68Ga) chloride solution, gallium (68Ga) edotreotide is indicated for PET imaging of somatostatin receptor overexpression in adults with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumours, to localise primary tumours and their metastases. It is given as a single injection into a vein, and the images are taken 40 to 90 minutes later. Because the tracer was already in established use, the company's evidence came from published studies covering 970 patients. The corpus's record for the related tracers gallium-68 and copper-64 DOTATATE is ga68-dotatate.
Edotreotide attaches to somatostatin receptors, which most well-differentiated gastroenteropancreatic neuroendocrine tumour cells carry in high amounts. Once labelled with gallium-68 it builds up on the tumour cells, and the PET camera detects the radiation to show where the tumours are and whether they have spread (EPAR summary, EMA).
| Region | Year | Indication |
|---|---|---|
| EU | 2016 | PET imaging of somatostatin receptor overexpression in adults with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NET), to localise primary tumours and metastases · Authorised 8 Dec 2016; Novartis Europharm Limited; orphan designation 19 Mar 2015 |
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Query for this drug: (TITLE:"Gallium-68 edotreotide" OR ABSTRACT:"Gallium-68 edotreotide" OR TITLE:"DOTATOC" OR ABSTRACT:"DOTATOC" OR TITLE:"SomaKit TOC" OR ABSTRACT:"SomaKit TOC" OR TITLE:"edotreotide" OR ABSTRACT:"edotreotide" OR TITLE:"68Ga-edotreotide" OR ABSTRACT:"68Ga-edotreotide" OR TITLE:"Ga-68 DOTATOC" OR ABSTRACT:"Ga-68 DOTATOC") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Gallium-68 edotreotide (DOTATOC), not a curated reading list.
Shares the tags universe-gap, ema-register, diagnostic.
Shares PET (positron emission tomography) and the tags universe-gap, diagnostic.
Shares Small intestinal neuroendocrine tumours, Pancreatic neuroendocrine tumours, Neuroendocrine tumours.
Shares Gallium-68 DOTATATE (and Cu-64 DOTATATE), Neuroendocrine tumours.
Shares Small intestinal neuroendocrine tumours, Pancreatic neuroendocrine tumours, Novartis, Neuroendocrine tumours.
Shares PET (positron emission tomography), PET/CT and the tag diagnostic.
Shares the tags universe-gap, ema-register.
Shares the tags universe-gap, ema-register.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/