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ESMO Open. 2020 Mar;5(2). pii: e000650. doi: 10.1136/esmoopen-2019-000650.

Safety, tolerability and clinical implementation of 'ready-to-use' 68gallium-DOTA0-Tyr3-octreotide (68Ga-DOTATOC) (SomaKIT TOC) for injection in patients diagnosed with gastroenteropancreatic neuroendocrine tumours (GEP-NETs).

Author information

1
The Christie NHS Foundation Trust, ENETS Centre of Excellence, Manchester, UK prakash.manoharan@christie.nhs.uk.
2
The Christie NHS Foundation Trust, ENETS Centre of Excellence, Manchester, UK.
3
Division of Cancer Science, The University of Manchester, Manchester, UK.
4
Royal Free London NHS Foundation Trust, ENETS Centre of Excellence, London, UK.
5
Advanced Accelerator Applications USA, New York, New York, USA.

Abstract

BACKGROUND:

68Ga-DOTA0-Tyr3-octreotide (68Ga-DOTATOC) positron emission tomography-CT (PET-CT) has superior diagnostic performance compared to the licensed tracer OctreoScan single photon emission CT-CT in patients with gastroenteropancreatic neuroendocrine tumours (GEP-NETs). A new preparation of 68Ga-DOTATOC using a new 'ready-to-use' 68Ga-DOTATOC formulation for injection has been developed (68Ga-DOTATOC (SomaKIT TOC)).

OBJECTIVES:

This study aimed to assess the safety and tolerability of 68Ga-DOTATOC (SomaKIT TOC) and evaluate the feasibility and robustness of implementing it in a NET clinical imaging service.

METHODS:

A first-in-human phase I/II multicentre, open-label study of a single dose of 68Ga-DOTATOC (SomaKIT TOC) 2 MBq/kg±10% (range 100-200 MBq) in patients with biopsy-proven grade 1-2 GEP-NETs. PET-CT was performed post injection. Patients were followed up for 28 days. We next implemented this new synthesis methodology in a clinical service assessed over 11 months.

RESULTS:

Twenty consenting patients were recruited; 14 males, 6 females; mean (SD) age 58 years (12); NET grade 1 (70%), grade 2 (30%); and 75% with stage IV disease. Twelve patients experienced at least one adverse event (AE) during the study with no grade 3-4 toxicities. Only four AEs were classified as possibly (headache (n=1; 4%), nausea (1; 4%)) or probably (dysgeusia (1; 4%), paraesthesia (1; 4%)) related to the study preparation. One hundred thirteen vials of 68Ga-DOTATOC (SomaKIT TOC) were synthesised with the 'kit' over a period of 11 months for clinical utility. Only 2/113 vials (1.77%) were rejected.

CONCLUSIONS:

The new ready-to-use preparation of 68Ga-DOTATOC (SomaKIT TOC) for injection was safe and well tolerated. This has led to the world's first (EMA) licensed 68Ga-DOTATOC (SomaKIT TOC) radiopharmaceutical for the utility of PET imaging in patients with NETs. This preparation can be robustly implemented into routine clinical practice.

KEYWORDS:

PET; SomaKIT-TOC; gallium; imaging; neuroendocrine

Conflict of interest statement

Competing interests: PM and JV declare Consulting/Advisory roles for AAA. PM, AL, JV and JC declare Speakers’ Bureau for AAA. AL has received education and travel support from AAA. MS was AAA’s Chief Medical Officer until September 2017 of and has continued her collaboration as Medical Advisor.

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