A Phase 1 interventional study of 177Lu-DOTA-EB-TATE in Neuroendocrine Tumors, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-12.
Sponsored by Peking Union Medical College Hospital · Phase 1, Interventional, and Treatment
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.
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.
Exclusion Criteria:
The patients were intravenously injected with single dose 0.50GBq-0.70GBq (13.5-18.9 mCi) of 177Lu-DOTA-EB-TATE and monitored at 2, 24, 72, 120 and 168 hours post-injection.
Drug: 177Lu-DOTA-EB-TATE
The patients were intravenously injected with single dose 0.50GBq-0.70GBq (13.5-18.9 mCi) of 177Lu-DOTA-EB-TATE and monitored at 2, 24, 72, 120 and 168 hours post-injection.
Standardized uptake value of 177Lu-DOTA-EB-TATE in normal organs and metastatic neuroendocrine Tumors
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and metastatic neuroendocrine tumors will be measured.
Time frame: 1 year
Adverse events collection
Adverse events within 2 months after the injection and scanning of patients will be followed and assessed
Time frame: 2 months
This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital