2. Academic Validation
  3. A pilot human-based study of 68Ga-FAPI-04 PET/CT in staging liver fibrosis and preliminary comparison to FIB-4 and fibroscan

A pilot human-based study of 68Ga-FAPI-04 PET/CT in staging liver fibrosis and preliminary comparison to FIB-4 and fibroscan

  • Sci Rep. 2026 Jan 11;16(1):5031. doi: 10.1038/s41598-025-34877-5.
Linwei Li # 1 2 3,  Lingzhi Chen # 4 5,  Dengsai Peng 1 2 3,  Mingxing Li 6,  Yue Chen 7 8 9
Affiliations

Affiliations

  • 1 Department of Nuclear Medicine, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China.
  • 2 Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province, Luzhou, Sichuan, 646000, China.
  • 3 Institute of Nuclear Medicine , Southwest Medical University , Luzhou, Sichuan, 646000, China.
  • 4 Department of Gynecology and Obstetrics , The Second Affiliated Hospital of Chongqing Medical University , Chongqing, 400010, China.
  • 5 Southwest Medical University , Luzhou, Sichuan Province, 646000, China.
  • 6 Department of Ultrasound , Affiliated Hospital of Southwest Medical University , Luzhou, Sichuan Province, China. [email protected].
  • 7 Department of Nuclear Medicine, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, 646000, China. [email protected].
  • 8 Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province, Luzhou, Sichuan, 646000, China. [email protected].
  • 9 Institute of Nuclear Medicine , Southwest Medical University , Luzhou, Sichuan, 646000, China. [email protected].
  • # Contributed equally.
PMID: 41521232 DOI: 10.1038/s41598-025-34877-5
Abstract

To explore the potential value of 68Ga-FAPI-04 PET/CT in staging liver fibrosis of patients with chronic liver diseases, and to preliminarily compare its diagnostic performance with Fibroscan and the fibrosis-4 (FIB-4) index. The single-center prospective study enrolled participants with chronic liver diseases who had undergone liver biopsy. 68Ga-FAPI-04 PET/CT grading is conducted through a scoring system: TBRliver−to−blood greater than 2 as F4, TBRliver−to−blood between 1 and 2 as F2/3, and TBRliver−to−blood less than 1 as F0/1. The diagnostic performance of 68Ga-FAPI-04 PET/CT was preliminarily compared with Fibroscan and FIB-4 using accuracy and weighted Kappa values. A total of 14 participants (8 men, 6 women) were enrolled. According to the METAVIR scoring system, 6 participants (43%) had F0/1 fibrosis, 4 (28%) had F2, and 4 (28%) had F4. The TBRliver−to−blood in the F0/1 group (0.83 ± 0.07) was significantly lower than that in the F4 group (2.12 ± 0.78) (P = 0.010). Using a TBRliver−to−blood > 1 for 68Ga-FAPI-04 to diagnose F ≥ 2 fibrosis yielded a sensitivity of 87.5%, specificity of 83.3%, and PPV of 87.5%. Both FIB-4 and Fibroscan correctly classified 10/14 (71.4%) participants (weighted Kappa values: 0.696 and 0.598, respectively). 68Ga-FAPI-04 PET/CT successfully differentiated 12/14 (85.7%) participants (weighted Kappa = 0.841). The results of this preliminary study suggest that 68Ga-FAPI-04 PET/CT may be an effective non-invasive method for assessing liver fibrosis and could potentially outperform FIB-4 and Fibroscan. Further clinical trials are warranted for validation.

Keywords

68Ga-FAPI-04; Fibroscan; Hepatitis B virus; Liver fibrosis; PET/CT.

Figures
Products
  • Cat. No.
    Product Name
    Description
    Target
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  • HY-128643
    99.47%, FAP Inhibitor
    FAP