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

NCT04605939 | Unknown

• 1 other identifier: XLan-0507
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Fibrosis; Positron Emission Tomography; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

• 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.

  2 years

• 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.

  2 years

Study Arms (1)

68Ga-DOTA-FAPI PET/MR

EXPERIMENTAL

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

Device: PET/MR; Device: PET/CT

Interventions

PET/MR DEVICE

Each subject undergoes PET/MR imaging within 40-60 minutes after injection.

Also known as: Positron Emission Tomography/Magnetic Resonance

68Ga-DOTA-FAPI PET/MR

PET/CT DEVICE

Each subject undergoes PET/CT imaging within 40-60 minutes after injection.

Also known as: Positron Emission Tomography/Computed Tomography

68Ga-DOTA-FAPI PET/MR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspected or diagnosed or treated liver fibrosis.
• Subjects are able to understand and sign the informed consent voluntarily, with good compliance.

You may not qualify if:

• Acute systemic diseases and electrolyte disorders.
• Pregnant or lactating women.
• Patients refuse to sign the informed consent.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

China, Hubei Province

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (3)

• Song Y, Qin C, Chen Y, Ruan W, Gai Y, Song W, Gao Y, Hu W, Qiao P, Song X, Lv X, Zheng D, Chu H, Jiang D, Yang L, Lan X. Non-invasive visualization of liver fibrosis with [68Ga]Ga-DOTA-FAPI-04 PET from preclinical insights to clinical translation. Eur J Nucl Med Mol Imaging. 2024 Oct;51(12):3572-3584. doi: 10.1007/s00259-024-06773-z. Epub 2024 Jun 8.

  PMID: 38850311 DERIVED

• 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.

  PMID: 34241652 DERIVED

• 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.

  PMID: 33452634 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Positron-Emission Tomography; Magnetic Resonance Spectroscopy; Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Radiography; Tomography, X-Ray

Study Officials

• Xiaoli Lan, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Xiaoli Lan, PhD

CONTACT

0086-027-83692633; lxl730724@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of nuclear medicine

Study Record Dates

• First Submitted: October 25, 2020
• First Posted: October 28, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

CN (1)