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

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ClinicalTrials.gov Identifier: NCT03478358
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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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 evaluate response to 177Lu-DOTAEB-TATE in patients with advanced metastatic neuroendocrine tumors. Different groups with doses of 0.37GBq-0.74GBq (10-20 mCi) and 1.85GBq (50 mCi)of 177Lu-DOTA-EB-TATE,3.7GBq (100 mCi)of 177Lu-DOTA-TATE will be injected intravenously. All patients will undergo 68Ga-DOTATATE PET/CT scans before and after the treatment.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: 177Lu-DOTA-EB-TATE 1 Drug: 177Lu-DOTA-TATE Drug: 177Lu-DOTA-EB-TATE 2 Drug: 177Lu-DOTA-EB-TATE 3 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 compare the efficacy of a long-lasting radiolabeled somatostatin analogue 177Lu-DOTA-EB-TATE with 177Lu-DOTA-TATE in patients with advanced metastatic neuroendocrine tumors.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment 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 : December 1, 2019
Estimated Study Completion Date : December 1, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 177Lu-DOTA-EB-TATE 1
The patients were intravenously injected with single dose 0.37GBq-0.74GBq (10-30 mCi) of 177LuDOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
 Drug: 177Lu-DOTA-EB-TATE 1
The patients were intravenously injected with single dose 0.37GBq-0.74GBq (10-30 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
Experimental: 177Lu-DOTA-EB-TATE 2
The patients were intravenously injected with single dose 1.85GBq (50 mCi) of 177LuDOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
 Drug: 177Lu-DOTA-EB-TATE 2
The patients were intravenously injected with single dose 1.85GBq (50 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
Experimental: 177Lu-DOTA-EB-TATE 3
The patients were intravenously injected with single dose 3.7 GBq (100 mCi) of 177LuDOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
 Drug: 177Lu-DOTA-EB-TATE 3
The patients were intravenously injected with single dose 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
Experimental: 177Lu-DOTA-TATE
The patients were intravenously injected with single dose 3.7 GBq (100 mCi) of 177LuDOTA-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
 Drug: 177Lu-DOTA-TATE
The patients were intravenously injected with single dose 3.7GBq (100 mCi) of 177Lu-DOTA-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Change of standardized uptake value of 68Ga-DOTA-TATE before and after the treatment in 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 before and after the treatment in metastatic neuroendocrine tumors will be measured.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 receptorexpressing 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.
Contacts and Locations
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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): NCT03478358


Contacts
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Contact: Hao Wang, PhD +86 10 69154196 474556259@qq.com

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Hao Wang, PhD.    +86 10 69154196      
Sponsors and Collaborators
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Study Chair: Zhaohui Zhu, M.D.,PhD Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03478358     History of Changes
Other Study ID Numbers: PekingUMCH-NM018
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents