Liver and Bile

Lancet Gastroenterol Hepatol. 2025;10(4):306-314

Nault JC, Boubaya M, Wartski M, Dohan A, Pol S, Pop G, Soussan M, Sutter O, Costentin C, Roux J, Sengel C, Lequoy M, Montravers F, Menu Y, Pageaux GP, Goulart DM, Guiu B, Luciani A, Nahon P, Dioguardi Burgio M, Wagner M, Maksud P, Mulé S, Allaire M, Sidali S, Coilly A, Besson FL, Lewin M, Regnault H, Hollande C, Amaddeo G, Ronot M, Ganne-Carrié N, Itti E, Bloch-Queyrat C, Levy V, Lebtahi R, Chalaye J, Bouattour M

[18F]fluorodeoxyglucose and [18F]fluorocholine PET-CT for staging optimisation and treatment modification in hepatocellular carcinoma (PET-HCC01): A prospective multicentre study

Background: The role of positron emission tomography with computed tomography (PET-CT) with [18F]fluorodeoxyglucose ([18F]FDG) and [18F]fluorocholine ([18F]FCH) in staging hepatocellular carcinoma and treatment decisions has, to the authors’ knowledge, never been prospectively assessed.
Methods: A multicentre prospective study (PET-HCC01) in 9 hospitals in France was conducted, including patients aged 18 years or older with a first diagnosis of hepatocellular carcinoma classified as Barcelona Clinic Liver Cancer (BCLC) classification A to C (without metastasis). At study inclusion, patients underwent contrast-enhanced liver magnetic resonance imaging and liver, chest, and pelvis CT scans. Patients subsequently underwent [18F]FCH and [18F]FDG PET-CT. A first tumour staging and treatment decision was recorded by the multidisciplinary tumour board at each centre using morphological imaging, blind to the results of the PET-CTs. After the results of the PET-CTs were revealed, a second tumour staging and treatment decision was recorded. The primary endpoint was the proportion of patients whose treatment was modified by PET-CTs. Analyses were done in the intention-to-image population, consisting of all patients who had undergone at least 1 PET-CT and were discussed by the multidisciplinary tumour board.
Findings: Between July 20, 2020, and April 27, 2023, 230 patients were enrolled. Among the 215 patients included in the intention-to-image population, the median age was 66.0 years (interquartile range, 60.0–71.5), 193 (90%) were male, and 155 (73%) had cirrhosis. Hepatocellular carcinoma was classified as BCLC stage A in 140 (65%) patients, B in 48 (22%), and C without metastasis in 27 (13%) on the basis of morphological imaging. Potential new lesions were identified in 19 (9%) patients by PET-CT (8 by both tracers, 6 by [18F]FCH only, and 5 by [18F]FDG only) and in 6 of these patients, follow-up confirmed the diagnosis of hepatocellular carcinoma (1 lesion in the adrenal gland, 2 in bones, 2 in the lymph node, and 1 intrahepatic). PET-CT modified BCLC stage in 10 patients: disease stage for 2 patients moved from BCLC A to B, from BCLC A to C for 2 patients, from BCLC B to C for 2 patients, and from BCLC C without metastasis to BCLC C with metastasis for 4 patients. Planned treatment was modified for 4 patients (2% [95% confidence interval: 1–5]), below the prespecified threshold of clinical significance (10%).

Interpretation: [18F]FDG and [18F]FCH PET-CTs should not be systematically performed for staging a first diagnosis of hepatocellular carcinoma, as they modified treatment decisions only in a minority of patients.

DOI:  10.1016/s2468-1253(25)00011-1