Intra-arterial Lutetium-177-dotatate for Treatment of Patients With Neuro-endocrine Tumor Liver M… (NCT03590119) | Clinical Trial Compass
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 range18 Years
SexALL
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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 …
What they're measuring
1
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.