- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05430841
Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT
June 20, 2022 updated by: The First Affiliated Hospital of Xiamen University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
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
-
-
Fujian
-
Xiamen, Fujian, China, 361000
- Recruiting
- The First Affiliated Hospital of Xiamen University
-
Contact:
- Haojun Chen, PhD
- Phone Number: 86 18659285282
- Email: leochen0821@foxmail.com
-
-
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
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: 18F-AlF-FAPI PET/CT
Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time.
|
Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy
Time Frame: 30 days
|
The sensitivity, specificity, and accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SUV
Time Frame: 7 days
|
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.
|
7 days
|
Number of lesions
Time Frame: 7 days
|
The numbers of positive primary and metastatic lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
June 1, 2022
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
June 20, 2022
First Submitted That Met QC Criteria
June 20, 2022
First Posted (Actual)
June 24, 2022
Study Record Updates
Last Update Posted (Actual)
June 24, 2022
Last Update Submitted That Met QC Criteria
June 20, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Liver Diseases
- Pancreatic Diseases
- Stomach Neoplasms
- Pancreatic Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Liver Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
Other Study ID Numbers
- XMYY-2021KY061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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