drugset / Trial / NCT03308682

177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors

NCT03308682

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, non-controlled, non-randomized study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluation safety and dosimetry of 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. A single dose of 0.50GBq-0.70GBq (13.5-18.9 mCi) of 177Lu-DOTA-EB-TATE will be injected intravenously. and monitored at 2, 24, 72,120 and 168 hours post-injection with semiquantitative method based on quantitative single-photon emission computed tomography/computed tomography (SPECT/CT) performance.

Timeline

Start
2017-04-30
Primary completion
2018-05-01
Completion
2018-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-DOTA-EB-TATE Peptide 500 mbq Intravenous
Subject 177Lu-DOTA-EB-TATE Peptide 700 mbq Intravenous