Overview

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

Status:
Recruiting
Trial end date:
2021-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Marnix Lam
Treatments:
Lutetium Lu 177 dotatate
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 ≤20% and a mitotic count
of ≤20.

- Confirmed presence of somatostatin receptors on target lesions, based on somatostatin
receptor imaging.

- Life expectancy of 6 months or longer.

- Eastern Cooperative Oncology Group (ECOG) performance score 0-1.

- 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).

- Presence of excessive liver metastases, defined as >25% tumor load, with or without
extrahepatic metastases.

- Patients must have clinical or radiological progressive disease.

- Negative pregnancy test for women of childbearing potential.

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 <3.0 g/dL.

- Glomerular filtration rate <50 ml/min.

- Hb <5.5 mmol/L; leucocytes <3.0x109/L; platelets <100x109/L (at baseline; 75x109/L is
sufficient for cycles 2-4).

- Uncontrolled congestive heart failure (NYHA II, III, IV).

- Uncontrolled diabetes mellitus.

- Patients suffering from diseases with an increased chance of liver toxicity.

- Patients suffering from psychic disorders that make a comprehensive judgement
impossible, such as psychosis, hallucinations and/or depression. Patients who are
declared incompetent.

- Previous enrolment in the present study or previous treatment with 177Lu-dotatate.

- Female patients who are not using an acceptable method of contraception (oral
contraceptives, barrier methods, approved contraceptive implant, long-term injectable
contraception, intrauterine device or tubal ligation) OR are less than 1 year
postmenopausal or surgically sterile during their participation in this study (from
the time they sign the consent form) to prevent pregnancy.

- 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.

- Body weight over 150 kg.

- Current spontaneous urinary incontinence.

- Severe allergy for i.v. contrast (Visipaque®), used for CT evaluation and treatment
angiography.