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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Neuroendocrine tumors (NETs) are a heterogeneous group of neoplasms that can develop anywhere in the body and arise from neuroendocrine cells throughout the endocrine system. The most recent NCCN guidelines for unresectable and metastatic NET recommend somatostatin analogues as first-line treatment, but do not recommend a particular treatment sequence for the remaining therapies. Radiolabeled somatostatin analogue therapy, also known as peptide receptor radionuclide therapy has become a well-accepted treatment for patients with well to moderately differentiated unresectable or metastatic NETs and disease progression after first-line treatment. However, a major problem in the therapeutic use of 177Lu-Dotatate has been its short half-life and fast rate of clearance. This study was designed to investigate the safety, dosimetry and preliminary effects of a long-lasting radiolabeled somatostatin analogue 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03308682
Study type	Interventional
Source	Peking Union Medical College Hospital
Contact	Jingjing Zhang, M.D.,PhD.
Phone	+86 10 69154196
Email	zhangjingjingtag@163.com
Status	Recruiting
Phase	Phase 1
Start date	April 30, 2017
Completion date	May 1, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01218555` - Study of Everolimus (RAD001) in Combination With Lenalidomide	Phase 1
Recruiting	`NCT03412877` - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer	Phase 2
Withdrawn	`NCT04614766` - A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors	Phase 1/Phase 2
Recruiting	`NCT05556473` - F-Tryptophan PET/CT in Human Cancers	Phase 1
Completed	`NCT03273712` - Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)	Phase 2
Recruiting	`NCT05636618` - Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors	Phase 1/Phase 2
Terminated	`NCT03986593` - Cryoablation of Bone Metastases From Endocrine Tumors	N/A
Recruiting	`NCT04584008` - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics	N/A
Completed	`NCT02815969` - The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors
Completed	`NCT02441062` - Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors	Phase 2
Active, not recruiting	`NCT02174549` - Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer	Phase 1/Phase 2
Completed	`NCT02132468` - A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers	Phase 2
Completed	`NCT02134639` - PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation	N/A
Recruiting	`NCT01201096` - Neo-adjuvant Peptide Receptor Mediated Radiotherapy With 177Lutetium in Front of Curative Intended Liver Transplantation in Patients With Hepatic Metastasis of Neuroendocrine Tumors (NEO-LEBE)	N/A
Terminated	`NCT01163526` - Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies	N/A
Completed	`NCT01099228` - Combination Targeted Radiotherapy in Neuroendocrine Tumors	N/A
Completed	`NCT00171873` - Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut	Phase 3
Active, not recruiting	`NCT05077384` - Open-label Study of Surufatinib in Japanese Patients	Phase 1/Phase 2
Active, not recruiting	`NCT04544098` - Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver	Early Phase 1
Active, not recruiting	`NCT02736500` - Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors	Phase 1/Phase 2