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Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors

Primary Purpose

Advanced Gastroenteropancreatic Neuroendocrine Tumor

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
68Ga-DOTATOC
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Advanced Gastroenteropancreatic Neuroendocrine Tumor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able and willing to provide a written informed consent; 18~75 years old,male or female； ECOG performance status 0 or 1; Confirmed or suspicion of GEP-NET. Exclusion Criteria: Unable to lie flat for the entire imaging duration (e.g. persistent cough, claustrophobia, severe arthritis, etc.), unable to enter the PET/CT device; Individuals planning to be pregnant, and lactating women; Individuals with concurrent active infections or with unexplained fever >38.5°C for more than 1 hour during the screening period or prior to administration of investigational medication.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PET/CT imaging with 68Ga-DOTATOC

    Arm Description

    Outcomes

    Primary Outcome Measures

    Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
    The number of patients with SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth
    Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
    The number of patients who have no SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth

    Secondary Outcome Measures

    Incidence and severity of AE and SAE

    Full Information

    First Posted
    October 16, 2023
    Last Updated
    October 16, 2023
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06091748
    Brief Title
    Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
    Official Title
    An Open-label, Single Arm Clinical Trial of Gallium (68Ga) Edotreotide PET-CT Scan for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2024 (Anticipated)
    Study Completion Date
    November 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jiangsu HengRui Medicine Co., Ltd.

    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
    This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Gastroenteropancreatic Neuroendocrine Tumor

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PET/CT imaging with 68Ga-DOTATOC
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    68Ga-DOTATOC
    Intervention Description
    Detection of somatostatin positive lesions in GEP-NETs
    Primary Outcome Measure Information:
    Title
    Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
    Description
    The number of patients with SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth
    Time Frame
    12 months
    Title
    Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
    Description
    The number of patients who have no SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Incidence and severity of AE and SAE
    Time Frame
    up to 1 year follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able and willing to provide a written informed consent; 18~75 years old,male or female； ECOG performance status 0 or 1; Confirmed or suspicion of GEP-NET. Exclusion Criteria: Unable to lie flat for the entire imaging duration (e.g. persistent cough, claustrophobia, severe arthritis, etc.), unable to enter the PET/CT device; Individuals planning to be pregnant, and lactating women; Individuals with concurrent active infections or with unexplained fever >38.5°C for more than 1 hour during the screening period or prior to administration of investigational medication.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jiaxing Yue
    Phone
    +0518-82342973
    Email
    jiaxing.yue@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors

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