- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04605939
Clinical Application of Fibroblast Activation Protein PET/MRI in Liver Fibrosis
Clinical Application of Fibroblast Activation Protein PET/MRI for Diagnosis and Staging in Liver Fibrosis
Study Overview
Status
Intervention / Treatment
Detailed Description
Liver fibrosis is a key step in the development of various chronic liver diseases (viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, autoimmune liver disease, etc.) to cirrhosis and an important link that affects the prognosis of chronic liver disease. Fibrosis is histologically reversible, and early liver fibrosis can still be reversed to restore liver tissue to normal. However, due to the lack of specific initial symptoms and accurate non-invasive diagnostic methods, the onset of liver fibrosis is insidious. Most patients have developed liver cirrhosis and/or hepatocellular carcinoma when they are diagnosed, and some even require liver transplantation. If liver fibrosis can be diagnosed accurately and treated early, the prognosis of chronic liver disease can be improved.
Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and staging of liver fibrosis. Activation of hepatic stellate cell (HSC) is a key link in the pathophysiological development of liver fibrosis. In human liver tissue, fibroblast activation protein (FAP) was only expressed in active HSCs and fibroblasts, but not in static HSCs. Therefore, FAP has become an excellent target for diagnosis and treatment of liver fibrosis. Recently, radionuclide-labeled fibroblast activation protein inhibitors (FAPI) as a new novel positron tracer has shown to be effective to detect various cancers. In this prospective study, the investigators will use the most advanced imaging equipments, integrated PET/MR, and PET/CT with gallium-68 (68Ga) -FAPI to image patients with or suspected of liver fibrosis, the aim is to explore the value of 68Ga-FAPI hybrid PET/MR and PET/CT in liver fibrosis.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430022
- Recruiting
- China, Hubei Province
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with suspected or diagnosed or treated liver fibrosis.
- Subjects are able to understand and sign the informed consent voluntarily, with good compliance.
Exclusion Criteria:
- Acute systemic diseases and electrolyte disorders.
- Pregnant or lactating women.
- Patients refuse to sign the informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 68Ga-DOTA-FAPI PET/MR
Investigators select subjects from patients with suspected or diagnosed or treated lievr fibrosis for 68Ga-DOTA-FAPI PET/MR imaging.
|
Each subject undergoes PET/MR imaging within 40-60 minutes after injection.
Other Names:
Each subject undergoes PET/CT imaging within 40-60 minutes after injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of 68Ga-DOTA-FAPI PET/MR for diagnosis and staging in liver fibrosis.
Time Frame: 2 years
|
For 100 subjects with suspected or diagnosed or treated liver fibrosis who have completed 18F-FDG PET/CT imaging, diagnosis and staging results of 68Ga-DOTA-FAPI PET/MR, PET/CT will be compared to transient elastography(TE), pathology, clinical and follow-up result.
|
2 years
|
Correlation of 68Ga-DOTA-FAPI PET/MR parameters and liver fibrosis progression.
Time Frame: 2 years
|
Analyze the correlation between the parameters displayed by 68Ga-DOTA-FAPI PET/MR and the pathological staging of liver fibrosis, serological scores, etc.
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Qin C, Song Y, Liu X, Gai Y, Liu Q, Ruan W, Liu F, Hu F, Lan X. Increased uptake of 68Ga-DOTA-FAPI-04 in bones and joints: metastases and beyond. Eur J Nucl Med Mol Imaging. 2022 Jan;49(2):709-720. doi: 10.1007/s00259-021-05472-3. Epub 2021 Jul 9.
- Zhang X, Song W, Qin C, Liu F, Lan X. Non-malignant findings of focal 68Ga-FAPI-04 uptake in pancreas. Eur J Nucl Med Mol Imaging. 2021 Jul;48(8):2635-2641. doi: 10.1007/s00259-021-05194-6. Epub 2021 Jan 15.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XLan-0507
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Magnetic Resonance Imaging
-
BayerCompletedMagnetic Resonance Imaging | Magnetic Resonance AngiographyPoland, China, France, Germany, Hungary, Korea, Republic of, South Africa, Spain, Thailand, Taiwan, Czech Republic, Hong Kong, Italy, Kazakhstan, Russian Federation, Bosnia and Herzegovina, Greece, Canada, Vietnam, Kyrgyzstan
-
Centre Hospitalier Régional Metz-ThionvilleUniversity of LorraineRecruitingMagnetic Resonance ImagingFrance
-
Jessa HospitalActive, not recruitingMagnetic Resonance ImagingBelgium
-
BayerCompletedMagnetic Resonance ImagingUnited States, Korea, Republic of, France, Germany, Italy, Switzerland, United Kingdom
-
Boston Scientific CorporationCompletedMagnetic Resonance ImagingSpain, Hong Kong, Germany, Israel, United Kingdom, Italy, United States, Malaysia, Belgium
-
Centre Hospitalier Universitaire, AmiensCompletedMagnetic Resonance ImagingFrance
-
MegaPro Biomedical Co. Ltd.CompletedMagnetic Resonance ImagingTaiwan
-
BayerCompletedMagnetic Resonance ImagingJapan
-
BayerCompletedMagnetic Resonance ImagingPhilippines
-
BayerCompletedMagnetic Resonance Imaging | Myocardial Perfusion ImagingSwitzerland, Germany, Austria, Poland
Clinical Trials on PET/MR
-
Washington University School of MedicineTerminatedCervical Cancer | Uterine Cervical Neoplasms | Uterine Cervical CancerUnited States
-
Maastricht University Medical CenterCompletedOvarian NeoplasmsNetherlands
-
University of Lausanne HospitalsSwiss National Science FoundationCompletedNeoplasmsSwitzerland
-
Massachusetts General HospitalUnknownCervical Cancer | Ovarian Cancer | Endometrial CancerUnited States
-
Zhejiang Cancer HospitalRecruiting
-
UNC Lineberger Comprehensive Cancer CenterTerminated
-
UNC Lineberger Comprehensive Cancer CenterTerminated
-
UNC Lineberger Comprehensive Cancer CenterCompleted
-
UNC Lineberger Comprehensive Cancer CenterWithdrawnBrain Metastasis | Brain Metastases | Brain LesionsUnited States