Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537193
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Abbreviated MRI Using Gadoxetic Acid Versus CT for Surveillance of Recurrent HCC After Curative Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multicenter Study for the Intra-Individual Comparison of Abbreviated MRI Using Gadoxetic Acid and Dynamic CT for Surveillance of Recurrent HCC After Curative Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hepatocellular carcinoma HCC often has a poor prognosis after curative treatment due to frequent recurrence Post-surgery 60-70 of HCC patients experience recurrence rising to 80 after ablation therapy This is partly because underlying cirrhosis or chronic liver disease remains increasing the risk of secondary HCC The risk of recurrence varies over time with a high risk in the first two years due to micro-metastasis Later recurrences are usually new primary cancers de novo HCC Therefore regular imaging tests such as computed tomography CT or magnetic resonance imaging MRI every three months in the first two years are necessary for early detection but guidelines for post-two-year screenings are unclear
Currently for patients recurrence-free for two years contrast-enhanced liver CT or MRI is performed every 3-6 months as a secondary screening test However repeated use of CT raises concerns about radiation exposure and iodine-based contrast agents can lead to side effects and kidney issues MRI with hepatocyte-specific agents like gadoxetic acid Primovist is effective but costly and time-consuming with potential side effects from repeated gadolinium exposure Therefore there is a need for a validated secondary screening method that is both effective and reduces patient risk
Abbreviated contrast-enhanced MRI using only essential sequences has shown promise in retrospective studies for detecting HCC However these studies have limitations such as potential bias and lack of data on repeated screenings There is limited research on secondary screening post-curative treatment for HCC This study aims to prospectively evaluate the use of abbreviated contrast-enhanced MRI with Primovist as a secondary screening method for detecting secondary HCC in patients who have been recurrence-free for more than two years
Currently for patients recurrence-free for two years contrast-enhanced liver CT or MRI is performed every 3-6 months as a secondary screening test However repeated use of CT raises concerns about radiation exposure and iodine-based contrast agents can lead to side effects and kidney issues MRI with hepatocyte-specific agents like gadoxetic acid Primovist is effective but costly and time-consuming with potential side effects from repeated gadolinium exposure Therefore there is a need for a validated secondary screening method that is both effective and reduces patient risk
Abbreviated contrast-enhanced MRI using only essential sequences has shown promise in retrospective studies for detecting HCC However these studies have limitations such as potential bias and lack of data on repeated screenings There is limited research on secondary screening post-curative treatment for HCC This study aims to prospectively evaluate the use of abbreviated contrast-enhanced MRI with Primovist as a secondary screening method for detecting secondary HCC in patients who have been recurrence-free for more than two years
Detailed Description:
A total of 455 subjects will be evaluated by two rounds of tests with both abbreviated MRI AMRI and dynamic CT to detect the occurrence of secondary HCC These two imaging tests are planned to be performed twice with a basic interval of 16 weeks between tests However considering the clinical practice of varying the imaging intervals based on the patients risk level the actual interval between tests can range from 4 to 8 months If a suspicious lesion indicative of HCC is detected during the study a recall examination using complete MRI will be performed within 3 months If the recall examination does not confirm the diagnosis a contrast-enhanced ultrasound or biopsy will be conducted The diagnosis of HCC will be made based on international guidelines with a histological confirmation or classification as Liver Imaging-Reporting and Data System LI-RADS category 5 After the completion of the two evaluation rounds at least 6 months of clinical follow-up data will be collected to record the occurrence of interval cancer If HCC is confirmed during the study the participant will be excluded from further study participation and the treatment will proceed according to current clinical processes If no lesions are detected during the two surveillance rounds follow-up for up to 6 months after the second test will be conducted according to current clinical processes If HCC is diagnosed which is the primary outcome of the study the study will be considered complete and this will not be treated as an adverse event of the study If a patient chooses not to continue participating in the study during the repeated application of the protocol the study for that patient will conclude even if the two rounds of testing are not completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None