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

Conditions: Gastroenteropancreatic neuroendocrine tumours, GEP-NET's.
MedDRA version: 14.1Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10071542Term: Neuroendocrine carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-000266-38-DK

Lead Sponsor: Department of Nuclear Medicine, Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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).