Targeted radionuclide therapy of neuroendocrine tumours using 177Lu-DOTATATE combined with induced local tumour up-regulation of somatostatin receptor expression for increased tumour dosage and tumour to background ratio - NET Therapy 177Lu-DOTATATE

Department of Nuclear Medicine, Odense University Hospital0 个研究点目标入组 50 人开始时间: 2012年5月31日最近更新: 2013年1月28日

试验速览

暂无简介。

•a.Inclusion criteria
•Neuroendocrine tumour (histopathologcally verified).
•Liver metastases on CT measurable as according to the RECIST 1.1 criteria.
•No further surgical options (including radiofrequency ablation (RFA)).
•Positive 111In- Octreotide scintigraphy and tumour uptake on the OctreoScan at least as high as normal liver parenchyma uptake, as judged from planar images, according to ENETS Consensus Guidelines (9) and/or positive baseline PET/CT with 68Ga-DOTATATE SUVmax for liver metastases at least as high as the SUVmax of normal liver parenchyma.
•Treatment with long-acting somatostatin formulations has been stopped at least 6 weeks before PRRT, and switched to short-acting formulations up to 1 day before PRRT.
•Age > 18 years.
•Performance status 0-1 (39).
•Informed consent obtained.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•b.Exclusion criteria (non-inclusion)
•Pregnancy or lactating.
•Women of childbearing potential and men who do not consent to use adequate contraception during the course of the study and 24 weeks after the last dose of protocol-specified therapy. Adequate contraceptive precautions include double barrier contraceptive methods (e.g. diaphragm and condom) or abstinence.
•Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedure.
•Severe co-morbidity (e.g. severe cardiac disease or AMI within 1 year of inclusion).
•Impaired haematological function. Hgb. < 5 mmol/L, platelets < 75 x 109/l, WBC < 2 x 109/l.
•Reduced kidney function (Cr-EDTA clearance < 60 mL/min).
•Severe hepatic impairment, i.e. total bilirubin >3 x upper limit of normal or albumin <30 g/l and prothrombin time increased ((9).
•Severe cardiac impairment.
•Prolonged (i.e. more than 2-3 months) WHO grade 3 or 4 haematological renal or hepatic toxicity (40).

发起方

Department of Nuclear Medicine, Odense University Hospital