4D Phase Contrast MR: Hypertrophy in Liver Cancer

Liver Cancer Clinical Trial

Official title:

4D Phase Contrast MR: Validation and Evaluation of Hypertrophy in Liver Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02618447
• Other study ID #: 201406079
• Status: Terminated
• Phase: N/A
• First received: November 18, 2015
• Last updated: April 5, 2017
• Start date: August 5, 2014
• Est. completion date: February 4, 2016

Study information

• Verified date: April 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that 4Dimensional Phase Contrast Magnetic Resonance Angiography (4D PC MRA) evaluation of portal venous flow predicts underlying liver function and hypertrophic potential in patients with liver cancer presenting for portal vein embolization (PVE). 4D PC MRA may provide a non-invasive measure of liver function that could help determine which patients could safely and successfully undergo PVE and subsequent resection of tumor. By comparing 4D PC MRA results with invasive catheter measurements the investigators will validate the flow findings. Further regression/correlation analysis with functional measures of the liver (HIDA scans), volumetrics, Doppler flow analysis, histology, and outcomes will help the investigators to determine the ability of 4D PC MRA to predict functional status and hypertrophic potential of the liver prior to PVE and hepatectomy allowing for better patient selection and reduced morbidity/mortality.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 4, 2016
• Est. primary completion date: February 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of malignant liver tumor

• Clinically referred for portal vein embolization

• At least 18 years of age

• Willing and able to provide informed consent

Exclusion Criteria:

• Documented or reported contrast allergy

• Unable to receive or tolerate MRI scan after evaluation of MRI screening form

• GFR (glomerular filtration rate) < 30 on labs drawn within 6 weeks of imaging.

Related Conditions & MeSH terms

• Cancer of the Liver
• Hypertrophy
• Liver Cancer
• Liver Neoplasms

Intervention

Device:
• 4Dimensional Phase Contrast Magnetic Resonance Angiography
4D PC MRA is a new non-contrast MRA technique that can measure flow of blood within vessels of interest over time.

Procedure:
• Portal vein embolization

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of the 4D PC MRA to measure portal venous flow findings compared to reference standards of catheter-based flow quantification	-Data from the 4D PC MRA will be compared with the reference standards of the catheter-based flow quantification to validate venous flow findings	Up to 6-8 weeks post PVE
Primary	Ability of the 4D PC MRA to measure flow velocities as compared to reference standards of the Doppler Flow Analysis	-Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure flow velocities	Up to 6-8 weeks post PVE
Primary	Ability of the 4D PC MRA to measure liver function	-4D PC MRA results will be compared with invasive catheter measurements to validate the portal venous flow findings. Regression/correlation analysis will be used to analyze association between 4D PC MRA and liver function. Residuals will be tested for normality with the Shapiro-Wilk W test, and if residuals are non-normally distributed, the Spearman's rank correlation coefficient will be used	Up to 6-8 weeks post PVE
Primary	Ability of the 4D PC MRA to measure hypertrophic potential (liver function is preserved)	-Data from the 4D PC MRA will be compared with the reference standards of the HIDA scan and biopsy specimens.	Up to 6-8 weeks post PVE
Primary	Ability of the 4D PC MRA to measure flow direction of flow as compared to reference standards of the Doppler Flow Analysis	-Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure direction of flow	Up to 6-8 weeks post PVE

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine