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

NCT03636607 | Withdrawn

• 1 other identifier: ZDWY.FZYX.001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Positron-Emission Tomography; Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Calculating the overall diagnostic sensitivity and specificity and ROC

  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 Outcomes (1)

• Calculating the overall diagnostic sensitivity and specificity and summarizing the intrinsic correlations

  60 minutes

Study Arms (2)

Non-metastatic group

EXPERIMENTAL

PET/CT dynamic scan,needle biopsy and gene detection

Diagnostic Test: PET/CT dynamic scan

Metastatic group

EXPERIMENTAL

PET/CT dynamic scan,needle biopsy and gene detection

Diagnostic Test: PET/CT dynamic scan

Interventions

PET/CT dynamic scan DIAGNOSTIC_TEST

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.

Also known as: Needle biopasy, Geen detection

Metastatic group; Non-metastatic group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Hongjun Jin

Zhuhai, Guangzhou, 519000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 17, 2018
• Study Start: June 13, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

CN (1)