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18F-FAPI PET Imaging in Pancreatic Adenocarcinoma

Sponsor
Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT05884463
Collaborator
(none)
62
Enrollment
1
Location
1
Arm
22.9
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To explore the potential efficacy of 18F-FAPI-04 PET/CT for PDAC tumour staging and compare the results with those obtained using 18F-FDG PET/CT.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Accurate diagnosis and staging are crucial for selecting treatment for patients with pancreatic ductal adenocarcinoma (PDAC). The desmoplastic responses associated with PDAC are often characterised by hypometabolism. Here we investigated 18F-fibroblast activation protein inhibitor (18F-FAPI-04) positron emission tomography/computed tomography (PET/CT) in evaluation of PDAC, and compared the findings with those obtained using (18F)-fluorodeoxyglucose (18F-FDG).

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
18F-FAPI PET/CT and 18F-FDG PET/CT in Patients With Pancreatic Adenocarcinoma : A Prospective, Single-Center, Comparative Study
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Feb 28, 2023
Actual Study Completion Date :
Feb 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan

Drug: 18F-FAPI
Intravenous injection of one dosage of 18F-FAPI.
Other Names:
  • (18)F-FAPI

    • Drug: 18F-FDG
    Intravenous injection of one dosage of 18F-FDG.
    Other Names:
  • (18)F-FDG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic value [1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)]

      Sensitivity and Specificity of 18F-FAPI PET/CT for diagnosis and staging in comparison with 18F-FDG PET/CT

    2. Maximum standardized uptake value [1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)]

      SUVmax of 18F-FAPI PET/CT for lesions in comparison with 18F-FDG PET/CT

    Secondary Outcome Measures

    1. Diagnostic efficacy for primary lesions [1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)]

      Sensitivity, specificity, accuracy of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT

    2. SUVmax for primary lesions [1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)]

      SUVmax of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT

    3. SUVmax for lymph node [1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)]

      SUVmax of 18F-FAPI PET/CT for lymph node in comparison with 18F-FDG PET/CT

    4. SUVmax for distant metastasis [1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)]

      SUVmax of 18F-FAPI PET/CT for distant metastasis in comparison with 18F-FDG PET/CT

    5. Correlation between the SUVmax of 18F-FAPI and 18F-FDG uptake in patients with different treatment response [at least 2 months after treatment]

      The correlation of SUVmax and treatment response

    Eligibility Criteria

    Criteria

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

    patients who were suspected to have PDAC by radiological imaging patients who underwent paired 18F-FAPI-04 PET/CT and 18F-FDG PET/CT for metastasis screening, recurrence confirmation, or tumour staging patients who were willing to participate in clinical trials and signed an informed consent form.

    Exclusion Criteria:

    patients with a history of severe contrast allergy pregnant patients patients who were not pathologically diagnosed as showing PDAC.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the First Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China 310003

    Sponsors and Collaborators

    • Zhejiang University

    Investigators

    • Study Director: Tingbo Liang, Ph.D., M.D., Zhejiang University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TingBo Liang, Professor, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05884463
    Other Study ID Numbers:
    • FAPIPDAC01
    First Posted:
    Jun 1, 2023
    Last Update Posted:
    Jun 1, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma
    Fluorodeoxyglucose F18

    Study Results

    No Results Posted as of Jun 1, 2023