Non-Alcoholic Fatty Liver DiseaseNCT06735118
Feasibility Study of Deep Learning-based MDixon Quant for Quantitative Assessment of Chemotherapy-induced Fatty Liver
A study testing Neoadjuvant chemotherapy in people with Non-Alcoholic Fatty Liver Disease, run by Yunnan Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Neoadjuvant chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CT/B ultrasound showed no fatty liver
- No MRI contraindications, including pacemaker, stent, metal implant, or claustrophobia
- Received neoadjuvant/adjuvant chemotherapy
Who cannot join
- Missing follow-up information
- Liver lesions (metastases, hemangioma, etc.)
- Poor image quality
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Guojun Zhang, Professor, 0871-68173640
About this study
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Neoadjuvant chemotherapy
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapyDrug
Also called Non
Neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant chemotherapy group | Experimental | Cancer patients undergoing chemotherapy. Receives: Drug: Neoadjuvant chemotherapy |
| Non-neoadjuvant chemotherapy group | No intervention | Cancer patients not undergoing chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extract the whole liver fat fraction
Extract the whole liver fat fraction using the threshold extraction method.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start25 Dec 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lianhua Ye, Study director, Ethics Committee of Yunnan Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735118
- Sponsor's protocol ID
- KYLX2023-165
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Deep Learning-based MDixon Quant for Quantitative Assessment of Chemotherapy-induced Fatty Liver
- ClinicalTrials.gov ID
- NCT06735118
- Acronym / sponsor ID
- KYLX2023-165
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemotherapy group | Experimental | Drug: Neoadjuvant chemotherapyCancer patients undergoing chemotherapy. |
| Non-neoadjuvant chemotherapy group | No intervention | –Cancer patients not undergoing chemotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CT/B ultrasound showed no fatty liver
- No MRI contraindications, including pacemaker, stent, metal implant, or claustrophobia
- Received neoadjuvant/adjuvant chemotherapy
Key exclusion criteria (3 listed)
- Missing follow-up information
- Liver lesions (metastases, hemangioma, etc.)
- Poor image quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant chemotherapyAlso: NonNeoadjuvant chemotherapy | Drug | neoadjuvant chemotherapy group |
Primary outcome
Extract the whole liver fat fraction
Time frame: one year
Extract the whole liver fat fraction using the threshold extraction method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lianhua Ye study director
Ethics Committee of Yunnan Provincial Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoadjuvant chemotherapy in people with Non-Alcoholic Fatty Liver Disease, run by Yunnan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lizhu Liu, Graduate (18287509587, liulizhu2022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extract the whole liver fat fraction (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.