T1rho Imaging of Liver in Presence of Iron

NCT05154643 | Completed

• 1 other identifier: 2018.235
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Fibrosis

Keywords

Quantitative rotating frame relaxometry, T1rho, early detection of liver fibrosis, hepatic iron

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Study Arms (2)

patients with liver fibrosis

healthy controls

Eligibility Criteria

• Age: Up to 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The patients with liver fibrosis and healthy controls will be screened before receiving MR exam.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wale Hospital

Hong Kong, Shatin, Hong Kong

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 13, 2021
• Study Start: August 1, 2019
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

HK (1)