Clinical Trial · NCT03590119

Intra-arterial Lutetium-177-dotatate for Treatment of Patients With Neuro-endocrine Tumor Liver Metastases

Overview

The objective is to investigate the impact of intra-arterial administration of 177Lu-dotatate on the intrahepatic biodistribution in patients with NET liver metastases. Our primary objective is to evaluate 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.

Sponsor

UMC Utrecht

Phase

Phase 2/3

Contacts

Marnix GEH Lam, MD PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03590119

Drug / Compound

DOTATATE

Isotope(s):

Target(s):

SSTR2

Ligand Class: Peptides

Chelator: DOTA

Eligibility

Inclusion

Presence of excessive liver metastases, defined as \>25% tumor load, with or without extrahepatic metastases.
Inoperable histologically proven neuro-endocrine tumor with indication for 177Lu-dotatate at enrollment time.
Patients must have clinical or radiological progressive disease.
Hepatic metastases with at least one lesion ≥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).
Eastern Cooperative Oncology Group (ECOG) performance score 0-1.
Confirmed presence of somatostatin receptors on target lesions, based on somatostatin receptor imaging.
Well-differentiated neuro-endocrine tumor with a Ki67-index ≤20% and a mitotic count of ≤20.

Exclusion

Male patients who are not surgically sterile or do not use an acceptable method of contraception during their participation in this study (from the time they sign the consent form) to prevent pregnancy in a partner.
Interferons, Everolimus (mTOR-inhibitors) or other systemic therapies within 4 weeks prior to randomization in the study.
Prior external beam radiation therapy to the liver.
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 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.
Serum bilirubin \> Upper Limit of Normal (ULN), serum albumin \<3.0 g/dL.
Patients suffering from diseases with an increased chance of liver toxicity.
Hb \<5.5 mmol/L; leucocytes \<3.0x109/L; platelets \<100x109/L (at baseline; 75x109/L is sufficient for cycles 2-4).
Glomerular filtration rate \<50 ml/min.