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Clinical Application of Fibroblast Activation Protein PET/MRI in Liver Fibrosis

Primary Purpose

Liver Fibrosis, Positron Emission Tomography, Magnetic Resonance Imaging

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PET/MR
PET/CT
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Fibrosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • China, Hubei ProvinceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-DOTA-FAPI PET/MR

Arm Description

Investigators select subjects from patients with suspected or diagnosed or treated lievr fibrosis for 68Ga-DOTA-FAPI PET/MR imaging.

Outcomes

Primary Outcome Measures

Sensitivity and specificity of 68Ga-DOTA-FAPI PET/MR for diagnosis and staging in liver fibrosis.
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.
Correlation of 68Ga-DOTA-FAPI PET/MR parameters and liver fibrosis progression.
Analyze the correlation between the parameters displayed by 68Ga-DOTA-FAPI PET/MR and the pathological staging of liver fibrosis, serological scores, etc.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2020
Last Updated
February 13, 2023
Sponsor
Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT04605939
Brief Title
Clinical Application of Fibroblast Activation Protein PET/MRI in Liver Fibrosis
Official Title
Clinical Application of Fibroblast Activation Protein PET/MRI for Diagnosis and Staging in Liver Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis, Positron Emission Tomography, Magnetic Resonance Imaging

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
68Ga-DOTA-FAPI PET/MR
Arm Type
Experimental
Arm Description
Investigators select subjects from patients with suspected or diagnosed or treated lievr fibrosis for 68Ga-DOTA-FAPI PET/MR imaging.
Intervention Type
Device
Intervention Name(s)
PET/MR
Other Intervention Name(s)
Positron Emission Tomography/Magnetic Resonance
Intervention Description
Each subject undergoes PET/MR imaging within 40-60 minutes after injection.
Intervention Type
Device
Intervention Name(s)
PET/CT
Other Intervention Name(s)
Positron Emission Tomography/Computed Tomography
Intervention Description
Each subject undergoes PET/CT imaging within 40-60 minutes after injection.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of 68Ga-DOTA-FAPI PET/MR for diagnosis and staging in liver fibrosis.
Description
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.
Time Frame
2 years
Title
Correlation of 68Ga-DOTA-FAPI PET/MR parameters and liver fibrosis progression.
Description
Analyze the correlation between the parameters displayed by 68Ga-DOTA-FAPI PET/MR and the pathological staging of liver fibrosis, serological scores, etc.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoli Lan, PhD
Phone
0086-027-83692633
Email
lxl730724@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoli Lan, PhD
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Chair
Facility Information:
Facility Name
China, Hubei Province
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoli Lan
Phone
0086-027-83692633
Email
lxl730724@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34241652
Citation
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.
Results Reference
derived
PubMed Identifier
33452634
Citation
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.
Results Reference
derived

Learn more about this trial

Clinical Application of Fibroblast Activation Protein PET/MRI in Liver Fibrosis

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