CompletedPhase 2/3

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

Netherlands26 participantsStarted 2018-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The 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.

Timeframe: 24 hours

Trial details

NCT IDNCT03590119

SponsorMarnix Lam

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-01

View on ClinicalTrials.gov More Neuroendocrine Tumors trials