68Ga-DOTATOC in patients with GEP-NETs
Research type
Research Study
Full title
Safety and tolerability of 68Ga-DOTATOC for injection in patients with proven gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs).
IRAS ID
160530
Contact name
Claude Hariton
Contact email
Sponsor organisation
Advanced Accelerator Applications SA
Eudract number
2014-002741-21
Research summary
This multicentric, open label study, sponsored by a French pharmaceutical company named Advanced Accelerator Applications SA, aims to assess the safety and tolerability of a single administration of a diagnostic radiopharmaceutical named 68Ga-DOTATOC, in patients suffering from gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs).
For the moment, Octreoscan® is the only approved agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors (NETs) bearing somatostatin receptors (sstr). However, promising sstr Positron Emission Tomography (PET) tracers, such as 68Ga-DOTATOC, are currently used for the characterization, staging and re-staging (diagnosis confirmation and disease management) of GEP-NETs, although no formal marketing authorization has been granted in the US or EU.
Several exploratory reports have indicated that 68Ga-DOTATOC has better diagnostic performances than Octreoscan® in patients with GEP-NETs, due to a higher affinity of DOTATOC for the relevant sstr subtypes, and a better intrinsic spatial resolution of the PET technique compared to Single Photon Emission Computed Tomography (SPECT).The Sponsor has developed a kit which combines lyophilized peptide with the eluate from a 68Ge/68Ga generator and buffer to prepare a ready-to-use 68Ga-DOTATOC formulation.
UK patients with proven GEP-NET will be recruited. Using the sponsor kit, the 68Ga-DOTATOC will be prepared prior to administration and injected intravenously on the day of the exam. Each patient will undergo one whole body PET scan, 40-60 min after administration. Safety assessments will be conducted after administration, then 7 and 28 days after the administration.
Briefly, adverse events will be recorded during the whole study period. Haematology, biochemistry and urine tests will be performed before and after the study product injection at several time points. Physical examination and vital signs will be recorded at each study visit. Electrocardiogram will be monitored at baseline and just after the administration.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/1133
Date of REC Opinion
23 Oct 2014
REC opinion
Further Information Favourable Opinion