Liver CancerHepaticaNCT03213314
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
A study testing Multiparameter magnetic resonance imaging in people with Liver Cancer and Surgery, run by University of Edinburgh at 2 sites in United Kingdom.
Trial summary
This observational clinical cohort study aims to evaluate the clinical utility of LiverMultiScan in quantifying liver health prior to liver resection or TACE. The results will enable further developments in scanning protocols and software, and clearly define the relevance of applying this technology as part of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Surgery, Liver Regeneration
- What is being tested?
- Multiparameter magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Sep 2017to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients being considered for liver resection
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Hampshire Hospitals Foundation Trust
Basingstoke
NHS Lothian Royal Infirmary of Edinburgh
Edinburgh
About this study
This observational clinical cohort study aims to evaluate the clinical utility of LiverMultiScan in quantifying liver health prior to liver resection or TACE. The results will enable further developments in scanning protocols and software, and clearly define the relevance of applying this technology as part of the pre-operative assessment of the patient being considered for liver resection or TACE.
Read the detailed description
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.
- Being tested
- Multiparameter magnetic resonance imaging
- Keywords
- LiverMultiScan, multiparameter MRI, functional liver remnant, liver resection, hepatic resection, portal vein embolisation, preoperative liver function, postoperative liver failure
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparameter magnetic resonance imagingDiagnostic test
Also called LiverMultiScan
LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.
| Study group | Role | What they receive |
|---|---|---|
| Main cohort | Experimental | Patients undergoing liver resection Receives: Diagnostic Test: Multiparameter magnetic resonance imaging |
| Nested cohort PVE | Experimental | Patients undergoing liver resection after portal vein embolisation Receives: Diagnostic Test: Multiparameter magnetic resonance imaging |
| Nested cohort neoadjuvant chemotherapy | Experimental | Patients undergoing liver resection after neoadjuvant chemotherapy Receives: Diagnostic Test: Multiparameter magnetic resonance imaging |
| Nested cohort TACE | Experimental | Patients undergoing trans arterial chemoembolisation for presumed hepatocellular carcinoma Receives: Diagnostic Test: Multiparameter magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the pre-operative liver health assessment score and the post-operative liver function composite integer-based risk score.
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.
Measured: 24 months
Secondary outcomes (2)
To compare LiverMultiScan image interpretations with histological findings
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
Measured: 24 months
• To evaluate LiverMultiScan image interpretations correlated with post-operative length of stay.
- 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start7 Sep 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Nested cohort study
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Hampshire Hospitals NHS Foundation Trust, Perspectum
- Responsible party
- Sponsor
- Investigators
- Damian J Mole, MBChB PhD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213314
- Sponsor's protocol ID
- AC17009
- Other IDs
- 223180
- Acronym
- Hepatica
- Status last verified
- Oct 2019
- First submitted
- 30 Jun 2017
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Controlled access of study data through a reasonable request to the study management team, after a reasonable embargo period after completion of the study
Publications
Mole DJ, Fallowfield JA, Sherif AE, Kendall T, Semple S, Kelly M, Ridgway G, Connell JJ, McGonigle J, Banerjee R, Brady JM, Zheng X, Hughes M, Neyton L, McClintock J, Tucker G, Nailon H, Patel D, Wackett A, Steven M, Welsh F, Rees M; HepaT1ca Study Group. Quantitative magnetic resonance imaging predicts individual future liver performance after liver resection for cancer. PLoS One. 2020 Dec 2;15(12):e0238568. doi: 10.1371/journal.pone.0238568. eCollection 2020.
PubMed 33264327Mole DJ, Fallowfield JA, Kendall TJ, Welsh F, Semple SI, Bachtiar V, Kelly M, Wigmore SJ, James Garden O, Wilman HR, Banerjee R, Rees M, Brady M. Study protocol: HepaT1ca - an observational clinical cohort study to quantify liver health in surgical candidates for liver malignancies. BMC Cancer. 2018 Sep 12;18(1):890. doi: 10.1186/s12885-018-4737-3.
PubMed 30208871
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
- ClinicalTrials.gov ID
- NCT03213314
- Acronym / sponsor ID
- Hepatica / AC17009
- Keywords
- LiverMultiScan, multiparameter MRI, functional liver remnant, liver resection, hepatic resection, portal vein embolisation, preoperative liver function, postoperative liver failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Hampshire Hospitals NHS Foundation Trust, Perspectum
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational clinical cohort study aims to evaluate the clinical utility of LiverMultiScan in quantifying liver health prior to liver resection or TACE. The results will enable further developments in scanning protocols and software, and clearly define the relevance of applying this technology as part of the pre-operative assessment of the patient being considered for liver resection or TACE.
Detailed description
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Nested cohort study
| Arm | Type | Receives |
|---|---|---|
| Main cohort | Experimental | Diagnostic Test: Multiparameter magnetic resonance imagingPatients undergoing liver resection |
| Nested cohort PVE | Experimental | Diagnostic Test: Multiparameter magnetic resonance imagingPatients undergoing liver resection after portal vein embolisation |
| Nested cohort neoadjuvant chemotherapy | Experimental | Diagnostic Test: Multiparameter magnetic resonance imagingPatients undergoing liver resection after neoadjuvant chemotherapy |
| Nested cohort TACE | Experimental | Diagnostic Test: Multiparameter magnetic resonance imagingPatients undergoing trans arterial chemoembolisation for presumed hepatocellular carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients being considered for liver resection
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparameter magnetic resonance imagingAlso: LiverMultiScanLiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase. | Diagnostic test | Main cohort, Nested cohort PVE, Nested cohort TACE, Nested cohort neoadjuvant chemotherapy |
Primary outcome
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.
2 secondary outcomes
To compare LiverMultiScan image interpretations with histological findings
Time frame: 24 months
• To evaluate LiverMultiScan image interpretations correlated with post-operative length of stay.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Derived from this study: PubMed 33264327Mole DJ, Fallowfield JA, Sherif AE, Kendall T, Semple S, Kelly M, Ridgway G, Connell JJ, McGonigle J, Banerjee R, Brady JM, Zheng X, Hughes M, Neyton L, McClintock J, Tucker G, Nailon H, Patel D, Wackett A, Steven M, Welsh F, Rees M; HepaT1ca Study Group. Quantitative magnetic resonance imaging predicts individual future liver performance after liver resection for cancer. PLoS One. 2020 Dec 2;15(12):e0238568. doi: 10.1371/journal.pone.0238568. eCollection 2020.
- Derived from this study: PubMed 30208871Mole DJ, Fallowfield JA, Kendall TJ, Welsh F, Semple SI, Bachtiar V, Kelly M, Wigmore SJ, James Garden O, Wilman HR, Banerjee R, Rees M, Brady M. Study protocol: HepaT1ca - an observational clinical cohort study to quantify liver health in surgical candidates for liver malignancies. BMC Cancer. 2018 Sep 12;18(1):890. doi: 10.1186/s12885-018-4737-3.
- Individual participant dataSharing planned: Yes. Controlled access of study data through a reasonable request to the study management team, after a reasonable embargo period after completion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damian J Mole, MBChB PhD principal investigator
University of Edinburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiparameter magnetic resonance imaging in people with Liver Cancer and Surgery, run by University of Edinburgh at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the pre-operative liver health assessment score and the post-operative liver function composite integer-based risk score. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03213314, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.