Ignite Creation Date:
2024-05-06 @ 10:02 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03140332
Status:
COMPLETED
Last Update Posted:
2020-07-20
First Post:
2017-04-27
Brief Title:
Contribution of the Perfusion Scanner in the Prediction of the Tumor Control of Patients With Hepatocellular Carcinoma Treated With Sorafenib
Sponsor:
Centre Hospitalier Universitaire Amiens
Organization:
Centre Hospitalier Universitaire Amiens
Study Overview
Official Title:
Contribution of the Perfusion Scanner in the Prediction of the Tumor Control of Patients With Hepatocellular Carcinoma Treated With Sorafenib
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCC-CTPerf
Brief Summary:
Hepatocellular carcinoma HCC is a hypervascular tumor The reference treatment of advanced forms of stage C according to the Barcelona classification BCLC C is sorafenib a multi-target tyrosine kinase inhibitor with predominant anti-angiogenic action In order not to underestimate the efficacy of sorafenib scannographic evaluation of the tumor response should be performed with mRECIST criteria that are significantly better correlated with survival These criteria take into account the tumor size and also the modification of the tumor contrast enhancement after anti-angiogenic treatment It seems appropriate to evaluate tumor control rather than tumor response since sorafenib is more stable than tumor response
This evaluation will be made according to the mRECIST criteria after 3 months of treatment since the progression-free survival is of the order of 3 to 4 months The determination of early predictive criteria for the response to sorafenib would optimize the management of advanced HCCs Indeed sorafenib only improves overall survival by 3 months in selected patients and with undesirable effects and a significant cost Predictive biological criteria have already been studied such as alpha foeto-protein AFP whose early decrease with sorafenib is associated with better overall survival The same applies to the early reduction at 4-6 weeks of tumor arterial contrast according to mRECIST criteria The perfusion scanner appears to be an accessible and reproducible choice imaging technique for assessing tumor vasculature In metastatic kidney cancers it was demonstrated that some criteria for tumor perfusion prior to treatment with sorafenib were predictive of better control of the disease and even a better tumor response according to the RECIST 11 criteria The determination of pre-therapeutic tumor perfusion criteria in order to predict tumor control or even overall survival has never been studied in advanced CHCs On the other hand an early variation in the criteria for tumor perfusion under treatment would tend to be correlated with the tumor response and even with overall progression-free survival
Therefore the study of tumor vascularization by the perfusion scanner could make it possible to demonstrate early predictive criteria for tumor control under sorafenib in order to optimize the management of patients with advanced HCC
This evaluation will be made according to the mRECIST criteria after 3 months of treatment since the progression-free survival is of the order of 3 to 4 months The determination of early predictive criteria for the response to sorafenib would optimize the management of advanced HCCs Indeed sorafenib only improves overall survival by 3 months in selected patients and with undesirable effects and a significant cost Predictive biological criteria have already been studied such as alpha foeto-protein AFP whose early decrease with sorafenib is associated with better overall survival The same applies to the early reduction at 4-6 weeks of tumor arterial contrast according to mRECIST criteria The perfusion scanner appears to be an accessible and reproducible choice imaging technique for assessing tumor vasculature In metastatic kidney cancers it was demonstrated that some criteria for tumor perfusion prior to treatment with sorafenib were predictive of better control of the disease and even a better tumor response according to the RECIST 11 criteria The determination of pre-therapeutic tumor perfusion criteria in order to predict tumor control or even overall survival has never been studied in advanced CHCs On the other hand an early variation in the criteria for tumor perfusion under treatment would tend to be correlated with the tumor response and even with overall progression-free survival
Therefore the study of tumor vascularization by the perfusion scanner could make it possible to demonstrate early predictive criteria for tumor control under sorafenib in order to optimize the management of patients with advanced HCC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None