Phase 4
N=96
Hepatic Xenetix-CT Perfusion
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01639703 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Blood Volume (BV) According to Degree of Lesions Differentiation — 15.930; 13.958 mL/100 grams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Xenetix-CT perfusion imaging (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Volume (BV) According to Degree of Lesions Differentiation |
15.930; 13.958 | — |
| PRIMARY Blood Flow (BF) According to Degree of Lesions Differentiation |
73.042; 72.051 | — |
| PRIMARY Permeability Surface (PS) According to Degree of Lesions Differentiation |
26.421; 27.750 | — |
| SECONDARY Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation |
43.234; 42.967 | — |
| SECONDARY Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation |
19.492; 13.708 | — |
| SECONDARY Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation |
62.725; 56.674 | — |
| SECONDARY Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation |
75.232; 80.834 | — |
| SECONDARY Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase) |
14.994; 12.964; 15.551 | 0.2476 |
| SECONDARY Blood Volume According to Immunohistochemistry Parameter (CD31) |
14.708; 15.589 | 0.5354 |
| SECONDARY Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase) |
79.178; 61.804; 74.261 | 0.3487 |
| SECONDARY Blood Flow According to Immunohistochemistry Parameter (CD31) |
70.057; 75.206 | 0.4195 |
| SECONDARY Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase) |
28.896; 24.840; 27.139 | 0.7127 |
| SECONDARY Permeability Surface According to Immunohistochemistry Parameter (CD31) |
25.434; 28.587 | 0.1753 |
Summary
The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC) and poorly/moderately differentiated HCC, in histo-pathologically proven HCC, and with the aim to cover the entire liver.
Eligibility Criteria
Inclusion Criteria
- Subjects diagnosed for HCC and planned for surgery (lobectomy or transplantation) within a timeframe of 30 days between first imaging procedure used for the study and surgery.
Exclusion Criteria
- Subjects who have undergone prior TACE (TransArterial Chemo Embolization), prior RFA (Radio Frequency Ablation) or prior SIRT (Selected Internal Radio Therapy) within one year before inclusion.
Data sourced from ClinicalTrials.gov (NCT01639703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.