Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT
Primary Purpose
Gastric Cancer, Pancreatic Cancer, Liver Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-FDG, 18F-AlF-FAPI PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Cancer focused on measuring Diagnosis, Positron-Emission Tomography, Gastric Cancer, Pancreatic Cancer, Liver Cancer
Eligibility Criteria
Inclusion Criteria:
- adult patients (aged 18 years or order);
- patients with suspected or newly diagnosed or previously treated gastrointestinal tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
- patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans;
- patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion Criteria:
- patients with non-malignant lesions;
- patients with pregnancy;
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Sites / Locations
- The First affiliated hospital of xiamen universityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-AlF-FAPI PET/CT
Arm Description
Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time.
Outcomes
Primary Outcome Measures
Diagnostic accuracy
The sensitivity, specificity, and accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.
Secondary Outcome Measures
SUV
Standardized uptake value (SUV) of 18F-FDG and 18F-AlF-FAPI PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.
Number of lesions
The numbers of positive primary and metastatic lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation.
Full Information
NCT ID
NCT05430841
First Posted
June 20, 2022
Last Updated
June 20, 2022
Sponsor
The First Affiliated Hospital of Xiamen University
1. Study Identification
Unique Protocol Identification Number
NCT05430841
Brief Title
Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT
Official Title
Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Xiamen 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 evaluate the potential usefulness of 18F-AlF-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in gastrointestinal tumors, and compared with 18F-FDG PET/CT.
Detailed Description
Subjects with gastrointestinal tumors underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 18F-AlF-FAPI, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Pancreatic Cancer, Liver Cancer
Keywords
Diagnosis, Positron-Emission Tomography, Gastric Cancer, Pancreatic Cancer, Liver Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18F-AlF-FAPI PET/CT
Arm Type
Experimental
Arm Description
Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time.
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-FDG, 18F-AlF-FAPI PET/CT
Intervention Description
Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time.
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Description
The sensitivity, specificity, and accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
SUV
Description
Standardized uptake value (SUV) of 18F-FDG and 18F-AlF-FAPI PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.
Time Frame
7 days
Title
Number of lesions
Description
The numbers of positive primary and metastatic lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients (aged 18 years or order);
patients with suspected or newly diagnosed or previously treated gastrointestinal tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans;
patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion Criteria:
patients with non-malignant lesions;
patients with pregnancy;
the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Long Sun, PhD
Phone
86 0592-2137077
Email
13178352662@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long Sun, PhD
Organizational Affiliation
The First Affiliated Hospital of Xiamen University
Official's Role
Study Chair
Facility Information:
Facility Name
The First affiliated hospital of xiamen university
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haojun Chen, PhD
Phone
86 18659285282
Email
leochen0821@foxmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT
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