Diagnostic Significance of Single Center, Open and Prospective Evaluation of <Sup>18<Sup>F-FDG PET/CT Dynamic Imaging and Genomic Sequencing in Detecting Metastatic Lesions of Primary Hepatocellular Carcinoma

March 20, 2025 updated by: Hongjun Jin, Fifth Affiliated Hospital, Sun Yat-Sen University
The aim of this study is to make up for this gap by performing a dynamic scan of 18F-FDG PET/CT on newly diagnosed patients with liver cancer. The lesions and/or metastases are performed for biopsy. Pathological and genomic studies are performed. The differences between tumor images and tissues are compared at the same time. 18F-FDG PET/CT dynamic imaging is explored in primary liver cancer metastases for the diagnostic value.

Study Overview

Status

Status

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Withdrawn

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.

Detailed Description

Hepatic malignancies have a high incidence rate and can be classified into primary liver cancer and metastatic liver cancer according to their sources. There are three main types of primary liver cancer: hepatocellular carcinoma (HCC), cholangiocellular carcinoma (CCC), and mixed hepatocellular carcinoma (both hepatocytes and cholangiolar cells). In recent years, the incidence and mortality of liver cancer have continued to rise. It has high incidence in Southeast Asia and Africa, and the number of liver cancer patients in China accounts for 55% of the world. However, the onset of liver cancer is occult; the degree of malignancy is high, and the progress rate is fast. Most patients have reached late stage or distant metastases when diagnosed. Imaging examination is an important method for the diagnosis and monitoring of liver cancer. The routine imaging examination mainly observed the morphological characteristics and blood supply changes of the liver lesions. The detection rates of CT and MRI for liver cancer can reach 81-89% and 50-80%, respectively. However, these imaging studies have limitations and are vulnerable to local anatomical locations and cannot be used to assess systemic tumor invasion and biological characteristics. Positron emission tomography (PET) is a molecular-level imaging technique that utilizes relatively specific tracers for qualitative and quantitative imaging. The good spatial and density resolutions of computed tomography (X-ray computed tomography, CT) play an important role in the localization and qualitative diagnosis of HCC. 18F-FDG PET/CT can provide functional imaging from the point of view of molecular biology. It not only can understand the tumor invasion of the whole body, but also has become an important means for qualitative diagnosis, staging, prognosis and therapeutic evaluation of tumors.

As a new imaging technology, 18F-FDG PET/CT plays an increasingly important role in the diagnosis of primary liver cancer. 18F-FDG PET/CT reflects the glycometabolism of tumor tissues. The diagnosis of benign and malignant tumors is based on the difference in glucose metabolism between tumor cells and normal tissues. 18F-FDG is an isomer of glucose and is involved in the glucose metabolism process. Since it is deoxygenated, it cannot generate diphosphate hexose, and it cannot participate in the next step of metabolism but remains in the cell. In the tumor cells, due to the high expression of glucose transporter mRNA, the glucose transporters Glut-1 and Glut-3 levels are increased; the expression of hexokinase is increased; the level of glucose-6-phosphatase is down-regulated and other common factors make the tumor cells' 18F-FDG uptake increased.

Previous researchers have found 18F-FDG PET/CT unsatisfactory in the diagnosis of HCC, especially for the diagnosis of HCC with well-differentiated tissue. The researchers also indicates that 18F-FDG PET/CT is not superior to traditional MRI and CT in the diagnosis of liver cancer. Combined with the current relevant research, it can be roughly stated that the positive rate of liver cancer using 18F-FDG PET/CT in diagnosing different grades of tissue differentiation is only about 50-70%. There appears to be a high uptake of FDG in poorly differentiated HCC. However, there is no such obvious phenomenon in HCC with medium or well-differentiated tissue. The PET/CT scans reported in all these documents are based on conventional static scans, i.e. the image data is based on a static take-up image of the tracer in tissue obtained at a fixed time point after the injection of 18F-FDG. To improve, the investigators propose to use dynamic data scanning, which captures the dynamic data of whole body tissues collected from the moment of injecting 18F-FDG to an hour. Dynamic scans can provide information on the dynamic changes in tracer metabolism and distribution in tissues over time, so they provide a richer metabolic and distributional pattern of tumor foci and metastases than static scans. However, the current domestic and international research on 18F-FDG PET/CT dynamic scan in the metastasis of hepatocellular carcinoma is very rare. Therefore, the aim of this study is to make up for this gap by performing a dynamic scan of 18F-FDG PET/CT on newly diagnosed patients with liver cancer. The lesions and/or metastases are performed for biopsy. Pathological and genomic studies are performed. The differences between tumor images and tissues are compared at the same time. 18F-FDG PET/CT dynamic imaging is explored in primary liver cancer metastases for the diagnostic value.

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.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
    • Guangzhou
      • Zhuhai, Guangzhou, China, 519000
        • Hongjun Jin

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Accurately diagnosing primary liver cancer according to pathological diagnostic criteria or clinical diagnostic criteria.
  • Tumor volume (> 1 cm) displayed by enhanced CT or MRI or liver mass confirmed by arteriography .
  • For patients considering distant metastases, trunk metastases need to be confirmed by CT examination. Bone metastases need to be confirmed by whole-body bone scan. Brain metastases need to be confirmed with characteristic metastatic tumors by MRI.
  • The age is more than 18 years old and less than 65 years old. There is no gender restriction.
  • Untreated patients who have not received surgery, interventional therapy, chemotherapy, biotherapy, and radiation therapy.
  • Physical condition score ECOG: 0-2; no major organ dysfunction; oxygen partial pressure ≥ 10.64kPa; white blood cell count≥ 4 × 109/L; hemoglobin ≥ 9.5g/dL; neutrophil absolute count ≥ 1.5 × 109 / L; platelet count ≥ 100 × 109 / L; total bilirubin ≤ 1.5 times of the upper limit of normal value; creatinine ≤ 1.25 times of the upper limit of normal value; and creatinine clearance ≥ 60ml / min.
  • Be able to obtain complete follow-up information, understand the situation of this study and sign informed consent.

Exclusion Criteria:

  • Poorly controlled diabetics (fasting blood glucose levels > 200 mg/dL).
  • In addition to four types of malignant tumors that can be treated with radical resection, such as cervical cancer in situ, basal or squamous cell skin cancer, (breast) ductal carcinoma in situ, and organ localized prostate cancer, suffering from any other malignant tumors within 5 years.
  • Breastfeeding and/or pregnant women.
  • Patients with severe bleeding tendencies (prothrombin time less than 50%, cannot be corrected by treatment with vitamin K, etc.).
  • Recent severe hemoptysis, severe cough, dyspnea or patients are not able to cooperate.
  • People with severe emphysema, pulmonary congestion, and pulmonary heart disease.
  • Researchers believe that the subject may not be able to complete this study or may not be able to comply with the requirements of this study (for management reasons or other reasons).

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Non-metastatic group
PET/CT dynamic scan,needle biopsy and gene detection
Diagnostic test: PET/CT dynamic scan
The purpose of this study is to carry out 18F-FDG PET/CT dynamic scans and biopsy of primary or primary and metastatic lesions in newly diagnosed patients with primary liver cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of 18F-FDG PET/CT dynamic imaging in primary liver cancer metastases are discussed.
Other Names:
  • Needle biopasy
  • Geen detection
Experimental: Metastatic group
PET/CT dynamic scan,needle biopsy and gene detection
Diagnostic test: PET/CT dynamic scan
The purpose of this study is to carry out 18F-FDG PET/CT dynamic scans and biopsy of primary or primary and metastatic lesions in newly diagnosed patients with primary liver cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of 18F-FDG PET/CT dynamic imaging in primary liver cancer metastases are discussed.
Other Names:
  • Needle biopasy
  • Geen detection

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
Calculating the overall diagnostic sensitivity and specificity and ROC
Time Frame: 60 minutes
For each patient enrolled in the study, a two-chamber four-parameter model (2TCM) and a Patlak two-parameter model are established using 18F-FDG PET/CT dynamic scans. Summarizing these dynamic model parameters for all enrolled patients separately calculates the overall diagnostic sensitivity and specificity. Calculate ROC based on sensitivity and specificity.
60 minutes

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
Calculating the overall diagnostic sensitivity and specificity and summarizing the intrinsic correlations
Time Frame: 60 minutes
Summarize the genetic testing of all enrolled patients and radiomic indicators to calculate the overall diagnostic sensitivity and specificity. At the same time, the intrinsic correlations between genomics, gene detection and histopathology are summarized.
60 minutes

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.
Fifth Affiliated Hospital, 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.
June 13, 2018

Primary Completion (Estimated)

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, 2025

Study Completion (Estimated)

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, 2025

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).
August 13, 2018

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.
August 15, 2018

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.
August 17, 2018

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.
March 25, 2025

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.
March 20, 2025

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.
March 1, 2025

More Information

Terms related to this study

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.
  • ZDWY.FZYX.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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