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

NCT ID: NCT06735118

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-25

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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neoadjuvant chemotherapy group

Cancer patients undergoing chemotherapy.

Group Type EXPERIMENTAL

Neoadjuvant chemotherapy

Intervention Type DRUG

Neoadjuvant chemotherapy

Non-neoadjuvant chemotherapy group

Cancer patients not undergoing chemotherapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neoadjuvant chemotherapy

Neoadjuvant chemotherapy

Intervention Type DRUG

Other Intervention Names

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Non

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yunnan Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lianhua Ye

Role: STUDY_DIRECTOR

Ethics Committee of Yunnan Provincial Cancer Hospital

Locations

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Yunnan Cancer Hospital

Kunming, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lizhu Liu, Graduate

Role: CONTACT

Phone: 18287509587

Email: [email protected]

Zhenhui Li, MD

Role: CONTACT

Phone: 13698736132

Email: [email protected]

Facility Contacts

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Guojun Zhang, Professor

Role: primary

Other Identifiers

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KYLX2023-165

Identifier Type: -

Identifier Source: org_study_id