18F-FAPI PET Imaging in Pancreatic Adenocarcinoma

May 31, 2023 updated by: TingBo Liang, Zhejiang University

18F-FAPI PET/CT and 18F-FDG PET/CT in Patients With Pancreatic Adenocarcinoma : A Prospective, Single-Center, Comparative Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • the First Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic value
Time Frame: 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
1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Maximum standardized uptake value
Time Frame: 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
1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic efficacy for primary lesions
Time Frame: 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
1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
SUVmax for primary lesions
Time Frame: 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
1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
SUVmax for lymph node
Time Frame: 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
1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
SUVmax for distant metastasis
Time Frame: 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
1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Correlation between the SUVmax of 18F-FAPI and 18F-FDG uptake in patients with different treatment response
Time Frame: at least 2 months after treatment
The correlation of SUVmax and treatment response
at least 2 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAPIPDAC01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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