Clinical trial · Observational
18F-FDG PET in HCC Patients Candidate to Treatment With Sorafenib
Exploring the Prognostic Role of 18F-FDG PET/CT Imaging in Patients Affected by Hepatocellular Carcinoma (HCC) and Candidate to Treatment With Sorafenib
NCT02977754CI-TRIAL-00047445completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The principal objective of this study is to explore the role of 18F-FDG PET in identifying sorafenib-induced metabolic shift in HCC, thus in predicting treatment response and disease outcome in advanced HCC patients candidate to systemic treatment with sorafenib.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| This is an observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Early change of metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib
- timeFrame
- Compare 18F-FDG uptake in HCC lesions at baseline and at 24 hours after the first administration of sorafenib.
- description
- Baseline parameters
Secondary outcomes (3)
- measure
- Change of metabolic characteristics (i.e. SUVmax, SUVmean, MTV, TLG) of HCC lesions under Sorafenib
- timeFrame
- Compare 18F-FDG uptake in HCC lesions at baseline and 1 week after the first administration of sorafenib.
- description
- Variation of parameters
- measure
- Predictive role of metabolic characteristics of HCC (i.e. SUVmax, SUVmean, MTV, TLG) lesions under Sorafenib
- timeFrame
- Correlate the patterns of 18F-FDG uptake in HCC lesions with objective tumor response assessed 8 weeks after the first administration of sorafenib according to mRECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with an histological diagnosis of HCC and scheduled to undergo systemic treatment with sorafenib; * obtained informed consent Exclusion Criteria: * patients age \<18 years * pregnancy or breast-feeding; * patients affected by other malignancies within the last 3 years, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin.
References
Publications (1)
- BACKGROUNDCastello A, Rimassa L, Personeni N, Pressiani T, Smiroldo V, Lopci E. Metabolic Switch in Hepatocellular Carcinoma Patients Treated with Sorafenib: a Proof-of-Concept Trial. Mol Imaging Biol. 2020 Oct;22(5):1446-1454. doi: 10.1007/s11307-020-01489-6. PMID 32206991