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Clinical Study of 68Ga Labeled HER2 Affibody Analogues

Primary Purpose

HER2-positive Breast Cancer and Gastric Cancer

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
68Ga labeled HER2 Affibody
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HER2-positive Breast Cancer and Gastric Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with breast or gastric cancers: diagnosed by MR and ready for surgery

Exclusion Criteria:

  • refuse or cannot endure surgery pregnant women

Sites / Locations

    Outcomes

    Primary Outcome Measures

    SUV of organs
    The standardized uptake values (SUV) in deferent organs

    Secondary Outcome Measures

    radioactivity of blood sample
    blood samples are obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes after the injection, for time-radioactivity curve calculations.

    Full Information

    First Posted
    June 5, 2022
    Last Updated
    June 5, 2022
    Sponsor
    Xijing Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05411432
    Brief Title
    Clinical Study of 68Ga Labeled HER2 Affibody Analogues
    Official Title
    Clinical Study of 68Ga Labeled HER2 Affibody Analogues in Healthy Volunteers and Patients With Breast or Gastric Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2022 (Anticipated)
    Primary Completion Date
    June 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Xijing 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
    The purpose of this study is to assess the dosimetric properties of the positron emission tomography (PET) imaging probe 68Ga labeled HER2 Affibody analogues and preliminarily evaluate its diagnosis value in patients with breast or gastric tumors.
    Detailed Description
    6 healthy volunteers with whole-body PET/CT scans at 0-1.0, 2.0, 3.0 and 4.0 hours after tracer injection (mean dose, 4.93 ± 0.10 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software. 50 patients with breast or gastric tumors will be enrolled for the clinical study, they will be performed with both 68Ga-HER2 Affibody PET/CT and18F-FDG PET/CT scans before surgery. The preoperative images are compared and correlated with the pathologically report. Next, the expression of HER2 will be determined by immunohistochemical staining of the resected brain tumor tissues.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HER2-positive Breast Cancer and Gastric Cancer

    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
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    68Ga labeled HER2 Affibody
    Intervention Description
    inject the tracer to subjects and perform PET/CT scans
    Primary Outcome Measure Information:
    Title
    SUV of organs
    Description
    The standardized uptake values (SUV) in deferent organs
    Time Frame
    0, 0.5, 1.0, 2.0,3.0 and 4.0 hours after injection
    Secondary Outcome Measure Information:
    Title
    radioactivity of blood sample
    Description
    blood samples are obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes after the injection, for time-radioactivity curve calculations.
    Time Frame
    1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients with breast or gastric cancers: diagnosed by MR and ready for surgery Exclusion Criteria: refuse or cannot endure surgery pregnant women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jing Wang, M.D, Ph.D
    Phone
    86-29-84775449
    Email
    wangjing@fmmu.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Study of 68Ga Labeled HER2 Affibody Analogues

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