Hepatic CancerNCT07704203
Preoperative 3D Magnetic Resonance Elastography for Predicting Surgical Risk in Patients Undergoing Hepatectomy
An observational study of Hepatic Cancer and Hepatocellular Carcinoma, run by Second Affiliated Hospital of Xi'an Jiaotong University.
Trial summary
How to accurately and safely evaluate regional liver function before hepatectomy remains an important unsolved problem in the surgical management of hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Cancer, Hepatocellular Carcinoma, Intrahepatic Cholangiocellular Carcinoma
- What is being tested?
- Three-Dimensional Magnetic Resonance Elastography
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll adult patients with primary or metastatic liver cancer, including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastases (e.g., from colorectal cancer), who are scheduled to undergo curative hepatectomy at the Second Affiliated Hospital of Xi'an Jiaotong University. Eligible patients will have preserved liver function (Child-Pugh class A or B) and adequate future liver remnant volume based on standard preoperative volumetric assessment. Patients will be consecutively recruited from the hepatobiliary surgery outpatient and inpatient services of the study center prior to their scheduled surgery.
Who may be able to join
- Age 18-80 years
- Pathologically or radiologically confirmed diagnosis of one of the following: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastasis (e.g., from colorectal cancer)
- Scheduled to undergo curative hepatectomy
- Child-Pugh class A or B liver function
- Able to tolerate MRI examination
- Provision of signed and dated informed consent
Who cannot join
- Contraindication to MRI (e.g., non-MRI-compatible implants, severe claustrophobia)
- Child-Pugh class C liver function
- Prior history of liver resection or liver transplantation
- Presence of extrahepatic metastasis
- Emergency surgery (e.g., due to tumor rupture)
- Severe cardiopulmonary or renal dysfunction precluding surgery
- Pregnant or breastfeeding women
- Unwillingness or inability to comply with study procedures or follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study on Preoperative Regional Liver Function Assessment Using Three-Dimensional Magnetic Resonance Elastography for Predicting Surgical Risk and Postoperative Liver Failure in Patients Undergoing Hepatectomy for Primary or Metastatic Liver Cancer
How to accurately and safely evaluate regional liver function before hepatectomy remains an important unsolved problem in the surgical management of hepatocellular carcinoma (HCC). We plan to develop a non-invasive, functional 3D-MRE-based method for preoperative regional hepatic functional reserve assessment, and to evaluate its ability to predict surgical risk and postoperative liver failure in patients with HCC undergoing hepatectomy.
- Conditions
- Hepatic Cancer, Hepatocellular Carcinoma, Intrahepatic Cholangiocellular Carcinoma, Metastatic Hepatocellular Carcinoma
- Being tested
- Three-Dimensional Magnetic Resonance Elastography
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Dimensional Magnetic Resonance ElastographyDevice
Patients scheduled for hepatectomy will undergo a preoperative three-dimensional magnetic resonance elastography (3D-MRE) examination in addition to standard-of-care evaluation. 3D-MRE will be used to quantify regional hepatic stiffness and viscoelastic parameters (including shear stiffness, storage modulus, loss modulus, and damping ratio) across different liver segments, with particular attention to the future liver remnant. These parameters will be analyzed for their association with postoperative liver function and the occurrence of post-hepatectomy liver failure. The examination does not alter the standard surgical decision-making process.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-Hepatectomy Liver Failure (PHLF)
Post-hepatectomy liver failure will be defined and graded according to the International Study Group of Liver Surgery (ISGLS) criteria (Grade A/B/C), based on postoperative bilirubin and INR values.
Measured: Within 90 days after surgery
Secondary outcomes (1)
Correlation between preoperative 3D-MRE regional stiffness parameters and future liver remnant function
Association between region-specific viscoelastic parameters (stiffness, storage modulus, loss modulus, damping ratio) and clinical liver function indices
Measured: Baseline (preoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704203
- Sponsor's protocol ID
- XJTUSAH-MRE-001
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Preoperative Regional Liver Function Assessment Using Three-Dimensional Magnetic Resonance Elastography for Predicting Surgical Risk and Postoperative Liver Failure in Patients Undergoing Hepatectomy for Primary or Metastatic Liver Cancer
- ClinicalTrials.gov ID
- NCT07704203
- Acronym / sponsor ID
- XJTUSAH-MRE-001
- Conditions
- Hepatic Cancer, Hepatocellular Carcinoma, Intrahepatic Cholangiocellular Carcinoma, Metastatic Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 15 Jul 2026 (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.
How to accurately and safely evaluate regional liver function before hepatectomy remains an important unsolved problem in the surgical management of hepatocellular carcinoma (HCC). We plan to develop a non-invasive, functional 3D-MRE-based method for preoperative regional hepatic functional reserve assessment, and to evaluate its ability to predict surgical risk and postoperative liver failure in patients with HCC undergoing hepatectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll adult patients with primary or metastatic liver cancer, including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastases (e.g., from colorectal cancer), who are scheduled to undergo curative hepatectomy at the Second Affiliated Hospital of Xi'an Jiaotong University. Eligible patients will have preserved liver function (Child-Pugh class A or B) and adequate future liver remnant volume based on standard preoperative volumetric assessment. Patients will be consecutively recruited from the hepatobiliary surgery outpatient and inpatient services of the study center prior to their scheduled surgery.
Key inclusion criteria (6 listed)
- Age 18-80 years
- Pathologically or radiologically confirmed diagnosis of one of the following: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastasis (e.g., from colorectal cancer)
- Scheduled to undergo curative hepatectomy
- Child-Pugh class A or B liver function
- Able to tolerate MRI examination
Key exclusion criteria (8 listed)
- Contraindication to MRI (e.g., non-MRI-compatible implants, severe claustrophobia)
- Child-Pugh class C liver function
- Prior history of liver resection or liver transplantation
- Presence of extrahepatic metastasis
- Emergency surgery (e.g., due to tumor rupture)
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 |
|---|---|---|
| Three-Dimensional Magnetic Resonance ElastographyPatients scheduled for hepatectomy will undergo a preoperative three-dimensional magnetic resonance elastography (3D-MRE) examination in addition to standard-of-care evaluation. 3D-MRE will be used to quantify regional hepatic stiffness and viscoelastic parameters (including shear stiffness, storage modulus, loss modulus, and damping ratio) across different liver segments, with particular attention to the future liver remnant. These parameters will be analyzed for their association with postoperative liver function and the occurrence of post-hepatectomy liver failure. The examination does not alter the standard surgical decision-making process. | Device | – |
Primary outcome
Incidence of Post-Hepatectomy Liver Failure (PHLF)
Time frame: Within 90 days after surgery
Post-hepatectomy liver failure will be defined and graded according to the International Study Group of Liver Surgery (ISGLS) criteria (Grade A/B/C), based on postoperative bilirubin and INR values.
1 secondary outcome
Correlation between preoperative 3D-MRE regional stiffness parameters and future liver remnant function
Time frame: Baseline (preoperative)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
Related trials for Hepatic Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 3
Personalized Adaptive Radiotherapy for Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC)
Not yet recruiting
Overcoming Immunotherapy Resistance in Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-Resectable
RecruitingPhase 2
Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma
Hepatocellular Carcinoma, HCC
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Cancer and Hepatocellular Carcinoma, run by Second Affiliated Hospital of Xi'an Jiaotong University.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Qu (+8613609117104, qukai001@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-Hepatectomy Liver Failure (PHLF) (time frame: Within 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2026.