Safety and tolerability of 68Ga-DOTATOC for injection in patients with proven gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs). - 68Ga-DOTATOC in patients with GEP-NETs

Advanced Accelerator Applications SA0 个研究点目标入组 20 人开始时间: 2014年9月3日最近更新: 2019年4月30日

适应症

试验速览

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•Patients with confirmed gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) where increased expression of somatostatin receptors is the diagnosis target in case of disease characterization, staging or restaging.
•Biopsy proven Grade I or II GEP-NET, as per WHO classification, confirmed by histology/ immuno-histochemistry.
•Staging assessed by CT/MRI within 3 months prior to enrolment.
•Age = 18 year old.
•ECOG Performance Status = 2.
•Females of childbearing potential must have a negative pregnancy test at screening/baseline.
•Absence of clinically significant ECG abnormalities.
•Ability to understand and sign an informed consent form.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Any patient receiving a treatment with short-acting Octreotide which cannot be interrupted for 24 h before administration of 68Ga-DOTATOC, or any patient receiving a treatment with long-acting SSA which cannot be interrupted for at least 4 weeks before the administration {i.e. 68Ga-DOTATOC administration should not be performed earlier than 4 weeks (+/- 3) days after the last administration of long-lasting SSA}.
•Pregnancy or lactation.
•Known hypersensitivity to the investigational drug or any of its components.
•Patients who have not provided a signed informed consent form to participate in the study, prior to the start of any protocol related activities.
•Patients who, within the last 30 days, have participated in any clinical study of a therapeutic agent which may interfere with the safety or efficacy analysis of the investigational product.
•Any other disease conditions, such as inflammatory or granulomatous diseases, or abnormal physical finding that may interfere with the study objective as judged by the investigator.

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