Noninvasive method to differentiate between benign and malignant liver tumors
Department of Ultrasonic Medicine, The First Affiliated Hospital of Air Force Medical University
This study is testing a new noninvasive ultrasound method to see if it can help tell the difference between harmless and harmful liver tumors in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Xi'an, Xi'an) |
| Trial ID | NCT06524557 on ClinicalTrials.gov |
What this trial studies
This observational study explores a noninvasive approach to differentiate between benign and malignant liver tumors using ultrasound-based parameters. It involves a retrospective analysis of demographic, clinical, and serological data from patients who underwent liver biopsy, which serves as the gold standard for diagnosis. The study employs receiver operating characteristic (ROC) curve analysis to evaluate the effectiveness of these ultrasound measures in distinguishing tumor types, particularly in patients with or without chronic liver disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 who have liver tumors that can be visualized via ultrasound and have undergone a liver biopsy or surgery.
Not a fit: Patients with liver metastatic tumors or those who have undergone previous surgical or therapeutic interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a safer and more accessible way for patients to receive accurate diagnoses of liver tumors without the need for invasive procedures.
How similar studies have performed: Other studies have shown promise in using noninvasive imaging techniques for tumor differentiation, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (1) age 18-70 years; (2) liver examination performed for all patients prior to US-guided liver biopsy or surgery; (3) tumor can be visualized in conventional US; (4) largest tumor sectional area saved in DICOM format for use in later analyses; (5) a histopathological diagnosis made either from US-guided liver biopsy or surgical resection; (6) suitable routine clinical and US data obtained within 7 days of the histopathological diagnosis. Exclusion Criteria: (1) unavailable pathological diagnosis; (2) liver metastatic tumors; (3) poor quality US images; and (4) a past history of surgical resection, percutaneous local ablation, radiation, transarterial and systemic therapies or liver transplantation.
Where this trial is running
Xi'an, Xi'an
- Xijing Hosptial — Xi'an, Xi'an, China (Recruiting)
Study contacts
- Study coordinator: Zhou Huihui, M.M.
- Email: huihui2807201830@163.com
- Phone: 15209239680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.