177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors
Safety and Dosimetry of a Long-lasting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE in Patients With Advanced Metastatic Neuroendocrine Tumors
2 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2017
CompletedFirst Submitted
Initial submission to the registry
October 8, 2017
CompletedFirst Posted
Study publicly available on registry
October 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedOctober 12, 2017
May 1, 2017
1 year
October 8, 2017
October 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (1)
Adverse events collection
2 months
Study Arms (1)
177Lu-DOTA-EB-TATE dosimetry calculation
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adults who had neuroendocrine tumors and had metastasized, that were with histologically confirmed, inoperable and had showed disease progression according to Response Evaluation Criteria in Solid Tumors \[RECIST\]. Tumors were with well-differentiated histologic features and a Ki67 index of 0 to 20%. Target tumors were selected from CT, MRI, and 68Ga-DOTA-TATE PET/CT, with confirmed somatostatin receptor-expressing and at least one lesion has higher uptake than that of normal liver parenchyma on 68Ga-DOTA-TATE PET imaging within 1 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhaohui Zhu, M.D.,PhD.
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2017
First Posted
October 12, 2017
Study Start
April 30, 2017
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
October 12, 2017
Record last verified: 2017-05