Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345508
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-28
Brief Title:
Early Detection of Liver Cancer by QUS
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Quantitative Ultrasound to Improve Detection and Diagnosis of Liver Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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:
QUS in HCC
Brief Summary:
Worldwide liver cancers are the third most common cause of cancer mortality Even when liver cancer is suspected by blood tests imaging is required to determine the location size and extent of disease Medical societies therefore recommend surveillance with ultrasound every 6 months in at-risk patients However a key challenge to improving the survival is that ultrasound may miss half of early-stage liver cancers thus diagnosis must rely on additional tests such as computed tomography CT magnetic resonance imaging MRI or biopsy Hence there is a clear need to improve the ability to detect liver cancers especially with ultrasound The investigators team proposes novel ultrasound approaches to detect cancer nodules invisible on conventional ultrasound based on differences in mechanical and structural properties between liver and tumor Improving detection is critical because liver cancer can be cured only if detected at an early stage as shown by improvements in survival rates in patients enrolled in surveillance programs The investigators multi-disciplinary national and international team includes experts in clinical fields hepatology oncology radiology pathology basic sciences engineering medical physics machine learning biostatistics and patient partnership The investirgator will apply the methodology of patient partner recruitment and collaborate with the Centre of Excellence on Partnership with Patients and the Public to select potential new collaborators This will permit this project to be informed at every stage by patient and family perspectives ensuring that the results of this project will be more robust impactful and aligned with the priorities needs and experiences of those who live with liver cancer The investigator submits a research proposal focused on advanced imaging techniques because imaging constitutes a foundation for surveillance diagnosis staging treatment selection and assessment of treatment response in patients with liver cancer
Detailed Description:
BACKGROUND Worldwide liver cancers are the third most common cause of cancer mortality In Canada hepatocellular carcinoma HCC is one of the few cancers for which mortality is increasing Early detection of HCC improves the likelihood of curative treatment and survival Systematic HCC surveillance with ultrasound US is recommended by practice guidelines However conventional B-mode US suffers from low sensitivity 47 for detecting early-stage HCC due to fatty liver obesity and cirrhosis Once a suspicious nodule is detected by US guidelines recommend contrast-enhanced computed tomography CT or magnetic resonance imaging MRI to confirm cancer Hence there is an urgent need to improve the ability to detect and diagnose HCC early Members of the investigators team have developed innovative quantitative ultrasound QUS techniques including shear wave viscoelastography SWV and sub-resolution cellular imaging that have a high diagnostic potential The investirgator hypothesizes that a combination of QUS techniques offering complementary assessment of tissue characteristics will improve our ability to detect liver nodules and diagnose HCC
METHODOLOGY Design Prospective cross-sectional imaging trial comparing head-to-head B-mode US and research QUS acquired within one month to the composite reference standard Reference standard MRI will be used as the non-invasive ground truth for liver nodules detection and classification except when biopsy is available Data analysis Lesion detectability will be measured by contrast-to-noise ratio on US and QUS maps for different size thresholds 10 mm 10-20 mm 20 mm used in diagnostic algorithms Diagnostic performance will be measured by receiver operating characteristic curve analysis on the training and test sets for different size thresholds The diagnostic accuracy of US and QUS B-mode US will be compared by using the DeLong method
RATIONALE AND IMPACT Early detection through systematic US surveillance translates into curative therapy in a higher proportion of patients and into improvements in survival rates This imaging trial will provide a low-cost imaging technique to identify liver cancers earlier and from a single exam Unlike some other imaging techniques US is widely available throughout Canada A major impact of this work for patients and medical institutions will be to lower the need for liver biopsy the risk of complications and the cost for HCC diagnosis This trial will position Canada as a leader in HCC diagnosis as new QUS and SWV biomarkers will be tested
METHODOLOGY Design Prospective cross-sectional imaging trial comparing head-to-head B-mode US and research QUS acquired within one month to the composite reference standard Reference standard MRI will be used as the non-invasive ground truth for liver nodules detection and classification except when biopsy is available Data analysis Lesion detectability will be measured by contrast-to-noise ratio on US and QUS maps for different size thresholds 10 mm 10-20 mm 20 mm used in diagnostic algorithms Diagnostic performance will be measured by receiver operating characteristic curve analysis on the training and test sets for different size thresholds The diagnostic accuracy of US and QUS B-mode US will be compared by using the DeLong method
RATIONALE AND IMPACT Early detection through systematic US surveillance translates into curative therapy in a higher proportion of patients and into improvements in survival rates This imaging trial will provide a low-cost imaging technique to identify liver cancers earlier and from a single exam Unlike some other imaging techniques US is widely available throughout Canada A major impact of this work for patients and medical institutions will be to lower the need for liver biopsy the risk of complications and the cost for HCC diagnosis This trial will position Canada as a leader in HCC diagnosis as new QUS and SWV biomarkers will be tested
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