Feasibility Study of Deep Learning-based MDixon Quant for Quantitative Assessment of Chemotherapy-induced Fatty Liver

Not Applicable

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Drug: Neoadjuvant chemotherapy

• Registration Number: NCT06735118
• Lead Sponsor: Yunnan Cancer Hospital

Brief Summary

The purpose of this study is to quantitatively assess the changes in liver fat content in cancer patients before and after treatment.

The main questions it aims to answer are:How does the liver fat fraction change before and after chemotherapy? In this study, patients undergoing mDixon Quant scanning are subjected to fully automated segmentation and measurement of liver fat content using artificial intelligence.

Detailed Description

Regarding the extraction of liver fat fraction, the traditional axial ROI method involves selecting several regions of interest (ROIs) at the largest cross-sectional level or across multiple continuous sections, and taking the average value as the whole-liver fat fraction. This method is complex, time-consuming, and cannot obtain the whole-liver fat fraction. In this study, a threshold extraction method is used to obtain the whole-liver fat fraction, enabling a 2D-to-3D conversion, which is more time-efficient and labor-saving, and provides a more accurate measurement.

Study Timeline

• Study Start: 2023-12-25
• Study First Submitted: 2024-11-27
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. CT/B ultrasound showed no fatty liver
2. No MRI contraindications, including pacemaker, stent, metal implant, or claustrophobia
3. Received neoadjuvant/adjuvant chemotherapy

Exclusion Criteria

1. Missing follow-up information
2. Liver lesions (metastases, hemangioma, etc.)
3. Poor image quality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neoadjuvant chemotherapy group	Neoadjuvant chemotherapy	Cancer patients undergoing chemotherapy.

Primary Outcome Measures

Name	Time	Method
Extract the whole liver fat fraction	one year	Extract the whole liver fat fraction using the threshold extraction method.

Trial Locations

Locations (1)

Yunnan Cancer Hospital; 🇨🇳 Kunming, Yunnan, China