T1rho Imaging of Liver in Presence of Iron

Liver Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05154643
• Other study ID #: 2018.235
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong, Prince of Wale Hospital	Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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