Fast breath-hold MRI to measure liver collagen (macromolecular proton fraction)
Assessment of Fibrosis by Non-invasive Quantitative Imaging of Collagen in the Liver Using Breath-hold MRI With Comparison With MR Elastography and Liver Biopsy
Chinese University of Hong Kong · NCT04429100
It tests whether a quick breath-hold MRI measurement called macromolecular proton fraction (MPF) can detect early-stage liver fibrosis in adults with or without liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong, Shatin) |
| Trial ID | NCT04429100 on ClinicalTrials.gov |
What this trial studies
This observational study uses a rapid breath-hold MRI sequence to produce quantitative maps of macromolecular proton fraction (MPF), an MRI parameter sensitive to collagen-related magnetization transfer effects. Participants include adults with histology-proven liver fibrosis across stages (including early-stage F1-2 and late-stage F3-4) and healthy adult controls. MPF values from the liver will be compared with histologic staging and clinical data to determine how well the imaging metric reflects collagen deposition and fibrosis stage. The goal is to refine a non-invasive imaging method that may detect early fibrosis better than current noninvasive options.
Who should consider this trial
Good fit: Ideal participants are adults (18+) with histology-proven liver fibrosis of any stage or healthy adult controls who can safely undergo MRI.
Not a fit: Patients with contraindications to MRI (for example, pacemakers, incompatible metallic implants), pregnancy, severe claustrophobia, or inability to hold their breath are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could provide a quick, non-invasive MRI biomarker to detect early liver fibrosis and reduce the need for biopsy.
How similar studies have performed: Previous smaller studies have reported that MPF quantification can detect collagen-related changes in liver fibrosis, but the approaches are still being developed and are not yet in wide clinical use.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient group * patients with histology-proven liver fibrosis, including those with liver fibrosis stage F0, early-stage liver fibrosis (F1-2), and late stage. liver fibrosis(F3-4). * patient aged 18 years old and above. 2. Healthy control group * controls aged 18 years old and above. Exclusion Criteria: * Contraindications to MRI, such as cardiac pacemaker, claustrophobia, pregnancy, metallic implants not suitable for MRI scan.
Where this trial is running
Hong Kong, Shatin
- The Chinese University of Hong Kong, Prince of Wale Hospital — Hong Kong, Shatin, Hong Kong (RECRUITING)
Study contacts
- Study coordinator: Weitian Chen, PhD
- Email: wtchen@cuhk.edu.hk
- Phone: 3505 1036
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.
Conditions: Liver Fibrosis, magnetic resonance imaging, quantitative imaging, spin-lock