HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies (Hepatica)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03213314 |
|
Recruitment Status :
Completed
First Posted : July 11, 2017
Last Update Posted : October 4, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Liver Cancer Surgery Liver Regeneration Colorectal Cancer Metastatic | Diagnostic Test: Multiparameter magnetic resonance imaging | Not Applicable |
The liver is unique among the abdominal organs for the capacity to regenerate post-operatively. However, a minimum functional liver remnant (FLR) is required for patients to survive the initial perioperative period. At present, the assessment of the FLR is based on volume alone, in the context of clinical judgment and surrogate markers of liver function based on blood tests. Recently, Perspectum Diagnostics have developed and validated LiverMultiScan, an MRI-based technology that can non-invasively quantify fibroinflammatory disease in addition to steatosis and iron content. In this project, we plan to use LiverMultiScan as an additional direct measurement of liver health prior to resectional surgery or transarterial chemoembolization (TACE), so that liver volume and function can be combined. For example, surgery with a predicted FLR of 21% might be survivable if the liver tissue was in extremely good health, whereas surgery with a predicted FLR of 40% might be lethal if the liver tissue was in poor health. Occasionally, portal vein embolization (PVE) is performed to promote hypertrophy of the FLR. Furthermore, non-resectional intervention, for example TACE for primary liver cancers, is well-tolerated by patients with healthy livers, but can lead to serious liver decompensation and liver failure if TACE is delivered to a liver in poor health. Currently, the available imaging modalities are limited in their ability to assess liver health in liver resection or TACE candidates. Liver fat content (steatosis) can be assessed with CT, or more accurately with MRI. However, fibroinflammatory disease, which has been shown to correlate with post-resection morbidity, typically requires an invasive biopsy to diagnose accurately.
This research project will support the definition, development and technical validation of Hepatica, which aims to build on the MRI technology underlying LiverMultiScan and develop the additional functionality required to meet this clinical need.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 149 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Nested cohort study |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies |
| Actual Study Start Date : | September 7, 2017 |
| Actual Primary Completion Date : | March 31, 2019 |
| Actual Study Completion Date : | March 31, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Main cohort
Patients undergoing liver resection
|
Diagnostic Test: Multiparameter magnetic resonance imaging
LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.
Other Name: LiverMultiScan |
|
Experimental: Nested cohort PVE
Patients undergoing liver resection after portal vein embolisation
|
Diagnostic Test: Multiparameter magnetic resonance imaging
LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.
Other Name: LiverMultiScan |
|
Experimental: Nested cohort neoadjuvant chemotherapy
Patients undergoing liver resection after neoadjuvant chemotherapy
|
Diagnostic Test: Multiparameter magnetic resonance imaging
LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.
Other Name: LiverMultiScan |
|
Experimental: Nested cohort TACE
Patients undergoing trans arterial chemoembolisation for presumed hepatocellular carcinoma
|
Diagnostic Test: Multiparameter magnetic resonance imaging
LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.
Other Name: LiverMultiScan |
- Correlation between the pre-operative liver health assessment score and the post-operative liver function composite integer-based risk score. [ Time Frame: 24 months ]Correlation between the pre-operative liver health assessment score (Hepatica score - calculated by weighting future remnant liver volume by liver inflammation and fibrosis (LIF) score) and the post-operative liver function composite integer-based risk (Hyder-Pawlik) score.
- To compare LiverMultiScan image interpretations with histological findings [ Time Frame: 24 months ]To compare LiverMultiScan image interpretations with clinical outcome after surgery in three domains: post-operative liver function, surgery-specific complication rate, and overall complication rate
- • To evaluate LiverMultiScan image interpretations correlated with post-operative length of stay. [ Time Frame: 24 months ]• To compare LiverMultiScan image interpretations with histological findings in the resected liver specimen in four domains: fibrosis, inflammation, fat content and iron load as title
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients being considered for liver resection
Exclusion Criteria:
- i. Patients under the age of 18 years will be excluded from the present study. ii. Prisoners will be excluded from the present study. iii. Persons unable to have an MRI scan (including but not limited to claustrophobia, implanted metallic devices, metal foreign body) iv. Adults with incapacity v. Non-provision of consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213314
| United Kingdom | |
| Hampshire Hospitals Foundation Trust | |
| Basingstoke, United Kingdom | |
| NHS Lothian Royal Infirmary of Edinburgh | |
| Edinburgh, United Kingdom | |
| Principal Investigator: | Damian J Mole, MBChB PhD | University of Edinburgh |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Edinburgh |
| ClinicalTrials.gov Identifier: | NCT03213314 History of Changes |
| Other Study ID Numbers: |
AC17009 223180 ( Other Identifier: IRAS ) |
| First Posted: | July 11, 2017 Key Record Dates |
| Last Update Posted: | October 4, 2019 |
| Last Verified: | October 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Controlled access of study data through a reasonable request to the study management team, after a reasonable embargo period after completion of the study |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
LiverMultiScan multiparameter MRI functional liver remnant liver resection |
hepatic resection portal vein embolisation preoperative liver function postoperative liver failure |
|
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Liver Diseases Liver Extracts Hematinics |