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

NCT03308682 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-10-12

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Zhaohui Zhu, M.D.,PhD. · Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03308682 on ClinicalTrials.gov