NCT06735118

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 25, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

November 27, 2024

Last Update Submit

December 13, 2024

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Extract the whole liver fat fraction

    Extract the whole liver fat fraction using the threshold extraction method.

    one year

Study Arms (2)

neoadjuvant chemotherapy group

EXPERIMENTAL

Cancer patients undergoing chemotherapy.

Drug: Neoadjuvant chemotherapy

Non-neoadjuvant chemotherapy group

NO INTERVENTION

Cancer patients not undergoing chemotherapy.

Interventions

Neoadjuvant chemotherapyDRUG

Neoadjuvant chemotherapy

Also known as: Non
neoadjuvant chemotherapy group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Lianhua Ye

    Ethics Committee of Yunnan Provincial Cancer Hospital

    STUDY DIRECTOR

Central Study Contacts

Lizhu Liu, Graduate

CONTACT

18287509587liulizhu2022@163.com

Zhenhui Li, MD

CONTACT

13698736132lizhenhui@kmmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 16, 2024

Study Start

December 25, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)