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

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ClinicalTrials.gov Identifier: NCT03308682
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : October 12, 2017
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: 177Lu-DOTA-EB-TATE Phase 1

Detailed 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Dosimetry of a Long-lasting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE in Patients With Advanced Metastatic Neuroendocrine Tumors
Actual Study Start Date : April 30, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 177Lu-DOTA-EB-TATE dosimetry calculation
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.




Primary Outcome Measures :
  1. Standardized uptake value of 177Lu-DOTA-EB-TATE in normal organs and metastatic neuroendocrine Tumors [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Adverse events collection [ Time Frame: 2 months ]
    Adverse events within 2 months after the injection and scanning of patients will be followed and assessed



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The exclusion criteria were a serum creatinine level of more than 150 μmol per liter, baseline measured GFR of less than 50 mL/min/1.73 m2, determined by 99mTc-DTPA renal function examination, a hemoglobin level of less than 8.0 g/dl, a white-cell count of less than 2.0× 109/L, a platelet count of less than 75 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia, and pregnancy or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308682


Contacts
Contact: Jingjing Zhang, M.D.,PhD. +86 10 69154196 zhangjingjingtag@163.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Zhaohui Zhu, M.D.,PhD.         
Sponsors and Collaborators
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
Study Chair: Zhaohui Zhu, M.D.,PhD. Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03308682     History of Changes
Other Study ID Numbers: PUMCH-EB-3
ZIAEB000073 ( U.S. NIH Grant/Contract )
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue