NCT04605939

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

Status unknown NA Last updated 14 February 2023

What this trial tests

NA trial testing PET/MR in Liver Fibrosis in 100 participants. Status unknown.

Timeline

1 July 2020

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	1 July 2020
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across China

Drugs / interventions tested

• PET/MR
• PET/CT

Conditions studied

• Liver Fibrosis — all drugs for Liver Fibrosis →
• Positron Emission Tomography — all drugs for Positron Emission Tomography →
• Magnetic Resonance Imaging — all drugs for Magnetic Resonance Imaging →

Sponsor

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

Who can join

Adults 18 to 80, any sex, with Liver Fibrosis or Positron Emission Tomography. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Non-oncologic incidental uptake on FAPI PET/CT imaging.
   Hotta M, Rieger AC, Jafarvand MG, Menon N, et al · · 2023 · cited 60× · PMID 35776566 · DOI 10.1259/bjr.20220463
2. Non-malignant findings of focal ⁶⁸Ga-FAPI-04 uptake in pancreas.
   Zhang X, Song W, Qin C, Liu F, et al · · 2021 · cited 43× · PMID 33452634 · DOI 10.1007/s00259-021-05194-6
3. Increased uptake of <sup>68</sup>Ga-DOTA-FAPI-04 in bones and joints: metastases and beyond.
   Qin C, Song Y, Liu X, Gai Y, et al · · 2022 · cited 39× · PMID 34241652 · DOI 10.1007/s00259-021-05472-3
4. Non-invasive visualization of liver fibrosis with [⁶⁸Ga]Ga-DOTA-FAPI-04 PET from preclinical insights to clinical translation.
   Song Y, Qin C, Chen Y, Ruan W, et al · · 2024 · cited 18× · PMID 38850311 · DOI 10.1007/s00259-024-06773-z
5. Fibroblast activation protein-based theranostics in pancreatic cancer.
   Cheng CS, Yang PW, Sun Y, Song SL, et al · · 2022 · cited 13× · PMID 36263225 · DOI 10.3389/fonc.2022.969731
6. Cancer-Associated Fibroblasts: Heterogeneity, Cancer Pathogenesis, and Therapeutic Targets.
   Li Y, Liu Q, Jing X, Wang Y, et al · · 2025 · cited 11× · PMID 40656546 · DOI 10.1002/mco2.70292