- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06287411
Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies
March 3, 2024 updated by: Xiao Chen
This study aimed to prospectively evaluate the utility of fibroblast activation protein inhibitor (FAPI) positron emission tomography (PET)/magnetic resonance (MR) combined with gadoxetate disodium in patients with clinical suspected hepatic malignancies (lesion diameter ≤ 3.0cm), with histopathological findings obtained from biopsy or resected surgical specimens, or follow-up results as reference standards.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
- Clinical and biological data, including the course of disease, underlying liver disease (hepatitis or cirrhosis), serum alpha-fetoprotein, carcinoembryonic antigen and carbohydrate antigen 19-9 levels were collected from each patient.
- PET image analysis: Each patient underwent both FAPI and fluorodeoxyglucose (FDG) PET/MR, including T1-weighted imaging (T1WI), T2-weighted imaging (T2WI), diffusion-weighted imaging (DWI), apparent diffusion coefficient (ADC) and gadoxetate disodium-enhanced MRI. Record and evaluate the following indicators: the maximum standardized uptake value (SUVmax) of lesions, the target-to-background ratio (TBR) which was calculated by dividing the SUVmax of the lesion by the background SUVmean obtained from nontumor liver tissue.
- Pathological analysis: Hematoxylin and eosin staining and immunohistochemical analyses will be performed. Immunohistochemical analysis will be used to investigate the expression of glucose transporter-1 (GLUT-1) and fibroblast activation protein (FAP).
Study Type
Observational
Enrollment (Estimated)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiao Chen, Ph.D
- Phone Number: +8615922970174
- Email: xiaochen229@foxmail.com
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400010
- Recruiting
- Department of Nuclear Medicine, Daping Hospital of Army Medical University
-
Contact:
- Xiao Chen, Ph.D
- Phone Number: 15922970174
- Email: xiaochen229@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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The subjects the investigators selected are adults who are not restricted by gender.
Description
Inclusion Criteria:
- Patient ≥ 18 years of age at the time of consent;
- Patients with suspected, newly diagnosed, or previously treated liver cancer;
- Estimated creatinine clearance > 30ml/min;
- Provided written informed consent authorisation before participating in the study.
Exclusion Criteria:
- Allergic to the gadoxetate disodium;
- MRI contraindications, not limited to cardiac implantable electronic devices and claustrophobia;
- Weight > 90Kg;
- Pregnancy or lactation;
- Active inflammation may affect FAPI imaging.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic performance
Time Frame: through study completion, an average of 2 years
|
sensitivity, specificity, accuracy, positive and negative predictive values
|
through study completion, an average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantitative parameters of PET/MR
Time Frame: completed within one week after the PET examination
|
the maximum standardized uptake value and tumour-to-background ratios
|
completed within one week after the PET examination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xiao Chen, Ph.D, Daping Hospital, Army Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
December 1, 2023
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
February 23, 2024
First Submitted That Met QC Criteria
February 23, 2024
First Posted (Actual)
March 1, 2024
Study Record Updates
Last Update Posted (Actual)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 3, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202436
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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