neuroendocriene tumoren (graad I&II) liver metastases NET neuroendocrine tumors
Conditions
Interventions
Treatment will be randomized between selective right or left hepatic artery
administration of 177Lu-dotatate (Four administrations of 7.4 GBq
each via the
same randomly allocated hepatic artery during angiography).
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients must have given written informed consent. - Female or male aged 18 years and over. - Inoperable histologically proven neuro-endocrine tumor with indication for 177Lu-dotatate at enrollment time. - Well-differentiated neuro-endocrine tumor with a Ki67-index =3 cm on cross sectional imaging in both the right and left liver lobe (i.e. left and right lobes are based on the hepatic arterial perfusion territory). - Presence of excessive liver metastases, defined as >25% tumor load. - Patients may or may not have extrahepatic metastases. - Patients must have clinical or radiological progressive disease. - Negative pregnancy test for women of childbearing potential.
Exclusion criteria
Exclusion criteria: - Any previous radioembolization, chemoembolization, or bland embolization, at any time, or surgery or radiofrequency ablation (or other ablative therapies) within 12 weeks prior to randomization in the study. - Prior external beam radiation therapy to the liver. - Interferons, Everolimus (mTOR-inhibitors) or other systemic therapies within 4 weeks prior to randomization in the study. - Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 hours before and 24 hours after the administration of 177Lu-dotatate, or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 4 weeks before the administration of 177Lu-dotatate, unless the tumor uptake on target lesions observed by imaging during continued Octreotide LAR treatment is higher than normal liver uptake. - Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.03) grade 2 from previous anti-cancer therapy. - Serum bilirubin > Upper Limit of Normal (ULN), serum albumin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess if there is a difference in post-treatment tumor-to-non-tumor (T/N) activity concentration ratio on SPECT/CT between the intra-arterial treated liver lobe and the intravenous treated liver lobe. The T/N activity concentration will be measured on SPECT/CT. The primary endpoint will be assessed after the first treatment cycle. The T/N activity ratios of the second, third, and final treatment cycle will be assessed as secondary endpoint. Tumor response, toxicity, extrahepatic uptake and kidney uptake are secondary endpoints. Intra- and inter-patient differences will be studied. | — |
Secondary
| Measure | Time frame |
|---|---|
| - There is a difference in absolute values of mean tumor and healthy liver absorbed dose on post-treatment SPECT/CT between the intra-arterial treated liver lobe and the intravenous treated liver lobe? - There is a difference in post-treatment tumor response between the intra-arterial treated liver lobe and the intravenous treated liver lobe? - There is a dose-response relation between tumor absorbed dose and post-treatment tumor response? - There is toxicity and how toxicity is compared to historical controls? - There is sufficient uptake of 177Lu-dotatate in extrahepatic lesions? - There is sufficient uptake of 177Lu-dotatate in the contralateral lobe, compared to historical controls? - There is a difference in kidney uptake of 177Lu-dotate between the IA treated patients and historical controls? - There is a difference in T/N activity concentration ratio between different timepoints post-injection? | — |
Countries
Netherlands
Outcome results
None listed