Hepatocellular CarcinomaNCT04715321
CT Perfusion Parameters Predict Vascular Pattern in Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- CT perfusion examination
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2013to 31 Dec 2021
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCC patients with tumor size of less than 5 cm who would receive liver resection.
Who may be able to join
- age over than 18 years old
- tumor size of less than 5 cm
- Child-Pugh A class liver function
- an Eastern Cooperative Oncology Group performance status of 0
- no previous treatment for HCC
- pathological diagnosis of hepatocellular carcinoma
- 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%)
Who cannot join
- Patients who received antitumor therapy before recurrence, including radiotherapy, transarterial chemoembolization, tyrosine kinase inhibitor, and immune checkpoint inhibitor
- a known medical history of HIV infection
- pregnancy or breastfeeding
- portal vein tumor thrombosis or hepatic vein thrombosis detected by any routine imaging modality, including ultrasonography, dynamic contrast CT and MRI
- any evidence of tumor metastasis or prior recurrence
- hepatic decompensation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, 510060
Ming Shi, MD, 8620-87343115, shiming@mail.sysu.edu.cn
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- CT perfusion examination
- Keywords
- hepatocellular carcinoma, CT perfusion parameters, vascular pattern
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT perfusion examinationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CT perfusion examination | |
| 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. Receives: Other: CT perfusion examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive performance of CT perfusion
The primary outcome of our study is to evaluate the sensitivity and specifity of CT perfusion in predicting vascular pattern of HCC
Measured: 6 months
Secondary outcomes (2)
Overall survival (OS)
OS is the length of time from the date of randomization until death from any cause
Measured: 6 months
Disease-free survival (DFS)
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start15 Feb 2013
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715321
- Sponsor's protocol ID
- SCT-01
- Status last verified
- Dec 2021
- First submitted
- 14 Jan 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Perfusion Parameters Predict Vascular Pattern in Hepatocellular Carcinoma: A Prospective Study
- ClinicalTrials.gov ID
- NCT04715321
- Acronym / sponsor ID
- SCT-01
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, CT perfusion parameters, vascular pattern
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Feb 2013 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Jan 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Other: CT perfusion examinationHCC patients enrolled in our study underwent a perfusion CT examination before surgery . We used CT perfusion parameters to predict the vascular pattern of tumors. |
| Validation cohort | – | Other: CT perfusion examinationHCC 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC patients with tumor size of less than 5 cm who would receive liver resection.
Key inclusion criteria (7 listed)
- age over than 18 years old
- tumor size of less than 5 cm
- Child-Pugh A class liver function
- an Eastern Cooperative Oncology Group performance status of 0
- no previous treatment for HCC
Key exclusion criteria (6 listed)
- Patients who received antitumor therapy before recurrence, including radiotherapy, transarterial chemoembolization, tyrosine kinase inhibitor, and immune checkpoint inhibitor
- a known medical history of HIV infection
- pregnancy or breastfeeding
- portal vein tumor thrombosis or hepatic vein thrombosis detected by any routine imaging modality, including ultrasonography, dynamic contrast CT and MRI
- any evidence of tumor metastasis or prior recurrence
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 |
|---|---|---|
| CT perfusion examinationCT 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. | Other | Training cohort, Validation cohort |
Primary outcome
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
2 secondary outcomes
Overall survival (OS)
Time frame: 6 months
Disease-free survival (DFS)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingPhase 2/3
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
HCC
Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
Hepatocellular Carcinoma
RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
RecruitingPhase 2
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Solid Tumors
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performance of CT perfusion (time frame: 6 months). 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 29 Dec 2021.