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Clinical Trials/NCT05154643
NCT05154643CompletedNot Applicable

Quantitative Rotating Frame Relaxometry for Early Detection of Liver Fibrosis in Presence of Hepatic Iron

Chinese University of Hong Kong1 site in 1 country50 target enrollmentStarted: August 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
The liver iron content will be measured using the established T2* MRI relaxometry

Study Overview

Brief Summary

Liver T1rho is elevated in response to accumulation of extracellular matrix proteins during fibrosis. The presence of hepatic iron overload; however, can shorten the T1rho value. With proper correction, we can remove this confounding factor and improve the reliability of T1rho for early diagnosis of liver fibrosis.

Patients with early-stage liver fibrosis confirmed by biopsy will be recruited at the Prince of Wales Hospital (Hong Kong). Thirty patients and twenty healthy volunteers will be recruited. The liver iron content will be measured using the established T2* MRI relaxometry. Breathhold black blood T1rho relaxometry will be used to collect T1rho data. The measured T1rho will be retrospectively corrected to remove the shortening effect caused by iron.

We will use ANOVA to compare the measurement with and without fibrosis. We will use Pearson correlations between the disease state and the imaging measurements, and ROC analysis to determine the diagnostic value of the proposed method.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 55 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Between age 18 and age 55
  • Informed written consent obtained

Exclusion Criteria

  • Contraindications to MRI such as the presence of metallic implants, claustrophobia and pregnancy

Outcomes

Primary Outcomes

The liver iron content will be measured using the established T2* MRI relaxometry

Time Frame: one year

Breathhold black blood T1rho relaxometry will be used to collect T1rho data. The measured T1rho will be retrospectively corrected to remove the shortening effect caused by iron.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chen Weitian

Associate Professor

Chinese University of Hong Kong

Study Sites (1)

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