NAULT
Bobigny, 93000, France
NCT Number: NCT04391348
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bobigny, 93000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Experimental procedure combining PET-TDM with 18F-FDG and PET-TDM with 18F-Fluorocholine
Time frame: through multidisciplinary concertation meeting an average of 3 days
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
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
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
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
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
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
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
Assistance Publique - Hôpitaux de Paris
Other
Prospective Study Evaluating the Combination of Positron Emission Tomography (PET) With 18F-FDG and 18 F-Fluorocholine for Optimization of Staging and Treatment Modification in Patients With Hepatocellular Carcinoma
Acronym: PET-HCC01
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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