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68Ga-HER2 Affibody PET/CT Imaging for HER2-Positive Cancer Patients

Sponsor
Tongji Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05535621
Collaborator
(none)
100
Enrollment
1
Location
48.4
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The prevalence of HER2 alterations in pan-cancer indicates a broader range of application of HER2-targeted therapies. immunohistochemistry (IHC) or amplification by fluorescence in situ hybridization (FISH) is currently the most commonly used method for evaluation of HER-2 status in cancer patients. However, biopsies are spatiotemporally limited because of the highly heterogeneous expression of HER2. Patients with false-negative HER2 results may miss the chance for targeted therapy. Additionally, the HER2 status can change during the disease process.

A investigational imaging tracer named 68Ga-HER2 Affibody binds to HER-2 receptors. Previous studies in human have shown the efficacy of 68Ga-HER2 Affibody in detecting HER2 positive breast cancer and gastric cancer without any observed toxicity. However, studies are still insufficient and limited to breast cancer and gastric cancer.

The investigators hypothesized that 68Ga-HER2 Affibody PET imaging can noninvasively assess HER2 status in metastatic or recurrent solid tumors including breast cancer, gastrointestinal tumors, head and neck squamous tumors, bladder cancer, lung cancer and uterine tumors lesion. In this study, efficacy of 68Ga-HER2 Affibody in detecting HER2 positive cancer lesions and change of patient management based on 68Ga-HER2 Affibody PET will be determined.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The prevalence of HER2 alterations in pan-cancer indicates a broader range of application of HER2-targeted therapies. Tumors including breast cancer, gastrointestinal tumors, head and neck squamous tumors, bladder cancer, lung cancer and uterine tumors exhibited high HER2 indices together with HER2 amplification or overexpression, which may benefit from HER2-targeted therapies.

    immunohistochemistry (IHC) or amplification by fluorescence in situ hybridization (FISH) is currently the most commonly used method for evaluation of HER-2 status in cancer patients. However, biopsies are spatiotemporally limited because of the highly heterogeneous expression of HER2. Patients with false-negative HER2 results may miss the chance for targeted therapy. Additionally, the HER2 status can change during the disease process.

    A investigational imaging tracer named 68Ga-HER2 Affibody binds to HER-2 receptors. Previous studies in human have shown the efficacy of 68Ga-HER2 Affibody in detecting HER2 positive breast cancer and gastric cancer without any observed toxicity. However, studies are still insufficient and limited to breast cancer and gastric cancer.

    The investigators hypothesized that 68Ga-HER2 Affibody PET imaging can noninvasively assess HER2 status in metastatic or recurrent solid tumors including breast cancer, gastrointestinal tumors, head and neck squamous tumors, bladder cancer, lung cancer and uterine tumors lesion. In this study, efficacy of 68Ga-HER2 Affibody in detecting HER2 positive cancer lesions and change of patient management based on 68Ga-HER2 Affibody PET will be determined.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    68Ga-HER2 Affibody PET/CT Imaging for HER2-Positive Cancer Patients
    Actual Study Start Date :
    Dec 18, 2021
    Anticipated Primary Completion Date :
    Dec 30, 2024
    Anticipated Study Completion Date :
    Dec 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. SUVmax [1 year]

      SUVmax

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    patients with clinically diagnosed HER2-Positive tumor subjects need to sign the informed consent

    Exclusion Criteria:
    • Pregnant women; renal failure (serum Cr>3mg/dl); Patients with claustrophobia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TongjiHospital Wuhan Hubei China 430030

    Sponsors and Collaborators

    • Tongji Hospital

    Investigators

    • Principal Investigator: ZHU XIAOHUA, DR, Tongji Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaohua Zhu, Professor, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT05535621
    Other Study ID Numbers:
    • TJ-IRB20211129
    First Posted:
    Sep 10, 2022
    Last Update Posted:
    Sep 10, 2022
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiaohua Zhu, Professor, Tongji Hospital
    HER2
    PET

    Study Results

    No Results Posted as of Sep 10, 2022