drugset / Trial / NCT03478358

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

NCT03478358

Phase 1 Unknown 60 enrolled Peking Union Medical College Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate response to 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. Different groups with doses of 0.37GBq-0.74GBq (10-20 mCi) and 1.85GBq (50 mCi)of 177Lu-DOTA-EB-TATE, 3.7GBq (100 mCi)of 177Lu-DOTA-TATE will be injected intravenously. Besides, we evaluated the safety and dosimetry of 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE with and without amino acid infusion. All patients will undergo 68Ga-DOTATATE PET/CT scans before and after the treatment.

Timeline

Start
2017-04-30
Primary completion
2022-12-31
Completion
2023-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-DOTA-EB-TATE Peptide 370 mbq Intravenous
Subject 177Lu-DOTA-EB-TATE Peptide 740 mbq Intravenous
Subject 177Lu-DOTA-EB-TATE Peptide 1850 mbq Intravenous
Subject 177Lu-DOTA-EB-TATE Peptide 3700 mbq Intravenous
Subject 177Lu-DOTATATE Peptide 3700 mbq Intravenous
Subject L-arginine Small molecule Intravenous
Subject Lysine Other / unclassified Intravenous