An interventional study of PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholine in Hepatocellular Carcinoma, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
The objective of this protocol is to obtain a better match between the actual staging and the proposed treatment in order to avoid inadequate treatments at risk of complications. In patients with HCC classified as BCLC A to C, the combination of 18F-FDG and 18F-Fluorocholine PET- TomoDensitoMetry (TDM) with conventional imaging would clinically significantly modify the therapeutic strategy initially planned by conventional imaging alone. This change in therapeutic strategy would be from curative to palliative treatment or from loco-regional palliative to systemic palliative treatment. 18F-FDG and 18F-Fluorocholine PET-CT scans will be performed after inclusion of the patient in the study and prior to multidisciplinary consultation meeting for treatment discussion.
Hepatocellular carcinoma (HCC) is one of the leading causes of death from cancer worldwide, developing on cirrhosis in 90% of cases. The prognosis of patients with HCC remains poor with an overall survival of around 10% at 5 years for all tumor stages combined. The diagnosis of HCC relies on non-invasive conventional imaging criteria (computed tomography [CT] and/or magnetic resonance imaging [MRI]) and/or histology. Conventional imaging (liver CT and/or MRI and lung CT) enables HCC staging according to the Barcelona Clinical Liver Cancer (BCLC) system, linking each stage to therapeutic modalities. Accurate staging with reliable imaging methods is therefore crucial to determine the best treatment strategy. The principal objective is to demonstrate that the identification of new tumor lesions by an experimental procedure combining 18F-FDG and 18F-Fluorocholine PET-CT scans in patients with HCC, modifies the initially planned therapeutic strategy of a curative treatment palliative treatment, from locoregional palliative treatment to systemic palliative treatment.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 230 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Exclusion Criteria:
PET-TDM with 18F-FDG and PET-TDM with 18F-fluorocholine
Radiation: PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholine
Experimental procedure combining PET-TDM with 18F-FDG and PET-TDM with 18F-Fluorocholine
Demonstrate that the identification of new tumour lesions by an experimental procedure combining PET-TDMs with 18F-FDG and 18F-Fluorocholine in patients with HCC modifies the initially planned therapeutic strategy
The primary objective of the study will be evaluated by the proportion of patients with a first diagnosis of HCC whose treatment initially planned in a multidisciplinary consultation meeting is modified by the combined use of PET-TDMs at 18F-FDG and 18F-Fluorocholine in combination with conventional imaging compared to conventional imaging alone.
Time frame: through multidisciplinary concertation meeting an average of 3 days
Number of patients for whom a curative treatment initially planned on the basis of conventional imaging has been modified, for a loco-regional or systemic palliative treatment by the experimental procedure (18F-FDG and 18F PET-CTs) -Fluorocholine)
The proportion of patients for whom curative treatment initially planned on the basis of conventional imaging has been modified for loco-regional or systemic palliative treatment by the experimental procedure (PET-TDMs at 18F-FDG and 18F-Fluorocholine).
Time frame: through multidisciplinary concertation meeting an average of 3 days
Modification of the BCLC tumor stage initially evaluated by conventional imaging on the basis of each PET-TDM (18F-FDG alone, 18F-Fluorocholine alone) separately and then the combination of both (combination of PET-TDMs with 18F-FDG and 18F-Fluorocholine
The proportion of modification of the tumor status to a more advanced status in the BCLC classification using PET/CT using 18F-FDG alone, 18F-Fluorocholine alone and then the combination of both in association with conventional imaging compared to conventional imaging alone
Time frame: through multidisciplinary concertation meeting an average of 3 days
Identification as a HCC of at least one additional tumour lesion using the experimental procedure (each PET-TDM separately and then the combination of both) compared to conventional imaging alone
The proportion of patients with an additional tumor lesion detected by 18F-FDG-PET alone, with 18F-Fluorocholine alone and then the combination of both, whose tumor nature is confirmed histologically or by imaging follow-up
Time frame: through multidisciplinary concertation meeting an average of 3 days
Description of the differences in diagnostic performance of the experimental procedure compared to the diagnostic gold standard (non-invasive criteria and/or tumor histology)
The proportion of new intrahepatic and/or extrahepatic lesions detected by PET-TDMs at 18F-FDG and 18F-Fluorocholine and confirmed as HCC on histology or by imaging follow-up
Time frame: through multidisciplinary concertation meeting an average of 3 days
Cost-effectiveness between PET-TDMs at 18F-FDG and 18F-Fluorocholine associated with conventional imaging versus conventional imaging alone
The (incremental) cost-effectiveness ratio of 18F-FDG and 18F-Fluorocholine PET-CTs associated with conventional imaging versus conventional imaging alone
Time frame: through multidisciplinary concertation meeting an average of 3 days
Number of patients who had an additional examination proposed by the MCM (multidisciplinary consultation meeting) following the PET-TDMs performed
The number of patients who have had an additional complementary examination (biopsy or new imaging for example) proposed by the MCM following 18F-FDG and 18F-Fluorocholine PET-CT scans will be collected prospectively
Time frame: through multidisciplinary concertation meeting an average of 3 days
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