Back to results18F-FAPI PET Imaging in Pancreatic Adenocarcinoma
Primary Purpose
18F-FAPI, 18F-FDG, Pancreas Adenocarcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-FAPI
18F-FDG
Sponsored by
About this trial
This is an interventional diagnostic trial for 18F-FAPI
Eligibility Criteria
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.
Sites / Locations
- the First Affiliated Hospital, School of Medicine, Zhejiang University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan
Outcomes
Primary Outcome Measures
Diagnostic value
Sensitivity and Specificity of 18F-FAPI PET/CT for diagnosis and staging in comparison with 18F-FDG PET/CT
Maximum standardized uptake value
SUVmax of 18F-FAPI PET/CT for lesions in comparison with 18F-FDG PET/CT
Secondary Outcome Measures
Diagnostic efficacy for primary lesions
Sensitivity, specificity, accuracy of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT
SUVmax for primary lesions
SUVmax of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT
SUVmax for lymph node
SUVmax of 18F-FAPI PET/CT for lymph node in comparison with 18F-FDG PET/CT
SUVmax for distant metastasis
SUVmax of 18F-FAPI PET/CT for distant metastasis in comparison with 18F-FDG PET/CT
Correlation between the SUVmax of 18F-FAPI and 18F-FDG uptake in patients with different treatment response
The correlation of SUVmax and treatment response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05884463
Brief Title
18F-FAPI PET Imaging in Pancreatic Adenocarcinoma
Official Title
18F-FAPI PET/CT and 18F-FDG PET/CT in Patients With Pancreatic Adenocarcinoma : A Prospective, Single-Center, Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
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
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
18F-FAPI, 18F-FDG, Pancreas Adenocarcinoma, Diagnosis, Staging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan
Intervention Type
Drug
Intervention Name(s)
18F-FAPI
Other Intervention Name(s)
(18)F-FAPI
Intervention Description
Intravenous injection of one dosage of 18F-FAPI.
Intervention Type
Drug
Intervention Name(s)
18F-FDG
Other Intervention Name(s)
(18)F-FDG
Intervention Description
Intravenous injection of one dosage of 18F-FDG.
Primary Outcome Measure Information:
Title
Diagnostic value
Description
Sensitivity and Specificity of 18F-FAPI PET/CT for diagnosis and staging in comparison with 18F-FDG PET/CT
Time Frame
1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Title
Maximum standardized uptake value
Description
SUVmax of 18F-FAPI PET/CT for lesions in comparison with 18F-FDG PET/CT
Time Frame
1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Secondary Outcome Measure Information:
Title
Diagnostic efficacy for primary lesions
Description
Sensitivity, specificity, accuracy of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT
Time Frame
1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Title
SUVmax for primary lesions
Description
SUVmax of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT
Time Frame
1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Title
SUVmax for lymph node
Description
SUVmax of 18F-FAPI PET/CT for lymph node in comparison with 18F-FDG PET/CT
Time Frame
1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Title
SUVmax for distant metastasis
Description
SUVmax of 18F-FAPI PET/CT for distant metastasis in comparison with 18F-FDG PET/CT
Time Frame
1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Title
Correlation between the SUVmax of 18F-FAPI and 18F-FDG uptake in patients with different treatment response
Description
The correlation of SUVmax and treatment response
Time Frame
at least 2 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tingbo Liang, Ph.D., M.D.
Organizational Affiliation
Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
the First Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Learn more about this trial
18F-FAPI PET Imaging in Pancreatic Adenocarcinoma
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