68Ga-DOTATATE PET/CT in Neuroendocrine Tumor
Primary Purpose
Neuroendocrine Tumors
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-DOTATATE
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Tumors
Eligibility Criteria
Inclusion Criteria:
- suspected or confirmed untreated NET patients previously performed 18F-FDG PET/CT signed written consent.
Exclusion Criteria:
- pregnancy breastfeeding known allergy against TATE any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.
Sites / Locations
- Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical ScienceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-DOTATATE PET/CT
Arm Description
Inject 68Ga-DOTATATE and then perform PET/CT scan
Outcomes
Primary Outcome Measures
SUVmax
SUVmax of focal lesions are measured on 68Ga-DOTATATE PET/CT. The SUVmax higher than that of the normal liver tissue is defined as positive.
Diagnostic value
Diagnostic value of 68Ga-DOTATE PET/CT for NET in comparison with 18F-FDG PET/CT
Secondary Outcome Measures
Diagnostic value in different grades/types of NET
Diagnostic value of 68Ga-DOTATATE PET/CT in ectopic ACTH-secreting tumor, insulinoma, glucagonoma and so on.
Overall Survival(OS)
Analysis of OS for patients receiving 68Ga-DOTATATE PET/CT
Progressive free survival(PFS)
Analysis of PFS for patients receiving 68Ga-DOTATATE PET/CT
SSTR expression/Ki67 and SUV
Correlation between SSTR expression/Ki 67 and SUV in PET
Risk stratification
Analysis of risk factors and OS/PFS
Full Information
NCT ID
NCT04041882
First Posted
July 30, 2019
Last Updated
July 30, 2019
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04041882
Brief Title
68Ga-DOTATATE PET/CT in Neuroendocrine Tumor
Official Title
68Ga-DOTATATE PET/CT for Detection and Evaluation of Neuroendocrine Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
January 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Somatostatin receptor(SSTR) was expressed in neuroendocrine tumor cells and SSTR-targeting molecular imaging(68Ga-DOTATATE PET/CT) could be a promising technique to evaluate the primary tumor and metastatic lesions of neuroendocrine tumors with higher accuracy. This prospective study is going to investigate whether radiolabeled somatostatin analogs 68Ga-DOTATATE PET/CT may be valuable for diagnosis, risk stratification, and prognostic evaluation of neuroendocrine tumors and compared it with 18F-FDG PET/CT.
Detailed Description
Neuroendocrine tumor(NET)can be derived from endocrine glands, endocrine tissues and endocrine cells from any parts of body. Due to its occult onset and heterogeneity, it is hard to be detected by conventional imaging like CT and it is often at late stage when diagnosed. New imaging modality such as 18F-FDG PET/CT have been well-accepted as a practical way to evaluate the aggressive of tumor. 18F-FDG PET/CT has been used to improve the efficacy in assessing the extent and severity of NET, but the diagnostic accuracy of 18F-FDG PET/CT decreased in low proliferation tumor cells and inflammation. Recent studies showed somatostatin receptor (SSTR) was expressed in NET cells and SSTR-targeting molecular imaging-68Ga-DOTATATE PET/CT could be a promising technique to evaluate the extent of NET with higher accuracy. Especially in some well differentiated tumor, 18F-FDG PET/CT can be negative, while 68Ga-DOTATATE PET/CT can be positive. However, the results can be varied in these two imaging modalities and characterized this disease at multiple levels such as clinical presentation, biologic characteristics, treatment response, and clinical outcome.This prospective study is going to investigate whether 68Ga-DOTATATE PET/CT may be superior to 18F-FDG PET/CT for diagnosis, risk stratification, and prognostic evaluation of NET.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-DOTATATE PET/CT
Arm Type
Experimental
Arm Description
Inject 68Ga-DOTATATE and then perform PET/CT scan
Intervention Type
Drug
Intervention Name(s)
68Ga-DOTATATE
Intervention Description
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-DOTATATE. Tracer doses of 68Ga-DOTATATE will be used to image lesions of NET PET/CT scan.
Primary Outcome Measure Information:
Title
SUVmax
Description
SUVmax of focal lesions are measured on 68Ga-DOTATATE PET/CT. The SUVmax higher than that of the normal liver tissue is defined as positive.
Time Frame
through study completion, an average of 3 years
Title
Diagnostic value
Description
Diagnostic value of 68Ga-DOTATE PET/CT for NET in comparison with 18F-FDG PET/CT
Time Frame
through study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
Diagnostic value in different grades/types of NET
Description
Diagnostic value of 68Ga-DOTATATE PET/CT in ectopic ACTH-secreting tumor, insulinoma, glucagonoma and so on.
Time Frame
through study completion, an average of 3 years
Title
Overall Survival(OS)
Description
Analysis of OS for patients receiving 68Ga-DOTATATE PET/CT
Time Frame
1 year and 5 years after been diagnosed
Title
Progressive free survival(PFS)
Description
Analysis of PFS for patients receiving 68Ga-DOTATATE PET/CT
Time Frame
1 year and 5 years after been diagnosed
Title
SSTR expression/Ki67 and SUV
Description
Correlation between SSTR expression/Ki 67 and SUV in PET
Time Frame
through study completion, an average of 3 years
Title
Risk stratification
Description
Analysis of risk factors and OS/PFS
Time Frame
through study completion, an average of 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
suspected or confirmed untreated NET patients previously performed 18F-FDG PET/CT signed written consent.
Exclusion Criteria:
pregnancy breastfeeding known allergy against TATE any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu, MD,PhD
Phone
+86-10-69154196
Email
zhuzhh@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD,PhD
Organizational Affiliation
Peking Union Medical College Hopital, Chinese Academy of Medical Science
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD,PhD
Phone
86-10-69154196
Email
zhuzhh@pumch.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34146130
Citation
Liu Q, Zang J, Yang Y, Ling Q, Wu H, Wang P, Lu L, Zhu Z. Head-to-head comparison of 68Ga-DOTATATE PET/CT and 18F-FDG PET/CT in localizing tumors with ectopic adrenocorticotropic hormone secretion: a prospective study. Eur J Nucl Med Mol Imaging. 2021 Dec;48(13):4386-4395. doi: 10.1007/s00259-021-05370-8. Epub 2021 Jun 19.
Results Reference
derived
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68Ga-DOTATATE PET/CT in Neuroendocrine Tumor
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