CT Perfusion Parameters Predict Vascular Pattern in Hepatocellular Carcinoma

December 28, 2021 updated by: Shi Ming, Sun Yat-sen University

Computed Tomography Perfusion Parameters Predict Vascular Pattern in Hepatocellular Carcinoma: A Prospective Study

Distinct vascular patterns (ECTC or Non-ECTC) of tumors plays an important role in tumor migration, metastasis and drug resistant in hepatocellular carcinoma (HCC). However, there is no non-invasive method to predict vascular pattern in clinical. In the present study, we prospectively assess CT perfusion parameters for evaluation of the vascular pattern in HCC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Cancer Center Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HCC patients with tumor size of less than 5 cm who would receive liver resection.

Description

Inclusion Criteria:

  1. age over than 18 years old
  2. tumor size of less than 5 cm
  3. Child-Pugh A class liver function
  4. an Eastern Cooperative Oncology Group performance status of 0
  5. no previous treatment for HCC
  6. pathological diagnosis of hepatocellular carcinoma
  7. adequate organ function (white blood cell count ≥3.0 × 109/L, absolute neutrophil count ≥1.5 × 109/L, platelet count ≥75 × 109/L, aspartate transaminase and alanine transaminase≤5 × upper limit of the normal, creatinine clearance rate of ≤1.5 × upper limit of the normal, and left ventricular ejection ≥45%)

Exclusion Criteria:

  1. Patients who received antitumor therapy before recurrence, including radiotherapy, transarterial chemoembolization, tyrosine kinase inhibitor, and immune checkpoint inhibitor
  2. a known medical history of HIV infection
  3. pregnancy or breastfeeding
  4. portal vein tumor thrombosis or hepatic vein thrombosis detected by any routine imaging modality, including ultrasonography, dynamic contrast CT and MRI
  5. any evidence of tumor metastasis or prior recurrence
  6. hepatic decompensation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Training cohort
HCC patients enrolled in our study underwent a perfusion CT examination before surgery . We used CT perfusion parameters to predict the vascular pattern of tumors.
Other: CT perfusion examination
CT perfusion was performed with a 64-section multidetector CT scanner. The following CT parameters were used to acquire dynamic data: blood flow (BF), blood volume (BV), mean transit time (MTT), permeability-surface area product (PS), hepatic artery ejection fraction (HAF), hepatic artery perfusion (HAP), and hepatic portal vein perfusion (PVP). And we used these parameters to predict the vascular pattern.
Validation cohort
HCC patients who would undergo a perfusion CT examination before surgery will be enrolled in our study from January 15, 2021. We use CT perfusion parameters to predict the vascular pattern of tumors.
Other: CT perfusion examination
CT perfusion was performed with a 64-section multidetector CT scanner. The following CT parameters were used to acquire dynamic data: blood flow (BF), blood volume (BV), mean transit time (MTT), permeability-surface area product (PS), hepatic artery ejection fraction (HAF), hepatic artery perfusion (HAP), and hepatic portal vein perfusion (PVP). And we used these parameters to predict the vascular pattern.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Predictive performance of CT perfusion
Time Frame: 6 months
The primary outcome of our study is to evaluate the sensitivity and specifity of CT perfusion in predicting vascular pattern of HCC
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 6 months
OS is the length of time from the date of randomization until death from any cause
6 months
Disease-free survival (DFS)
Time Frame: 6 months
Disease-free survival is calculated from the date of surgery to tumor recurrence or death from any cause (or the date of the last follow-up if the patient was alive)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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