NCT02095678

Assessment of Novel MRI Quantification Free Breathing Technique in Evaluation of Liver Lesions

Completed NA Results posted Last updated 30 June 2022

What this trial tests

NA trial testing liver biopsy in Hepatocellular Carcinoma in 52 participants. Completed in 3 December 2019.

Timeline

1 December 2013

Primary endpoint
3 December 2019

3 December 2019

Quick facts

Lead sponsor	Case Comprehensive Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	52
Start date	1 December 2013
Primary completion	3 December 2019
Estimated completion	3 December 2019
Sites	1 location across United States

Drugs / interventions tested

• liver biopsy — full drug profile →
• free-breathing MRI

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Case Comprehensive Cancer Center — full company profile →

Who can join

Adults 18 to 100, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Arterial Fraction Primary · 1 day, At time of Research MRI

Dynamic Contrast Enhanced MRI data were used to calculate three quantitative perfusion properties using a dual input, single tissue compartment model of gadolinium based contrast agents in the liver in HCC, metastatic, and benign lesions. One of these quantitative perfusion properties is Mean Arterial fraction, which is the proportion of blood flow derived from hepatic artery.

Group	Value	95% CI
Dynamic Contrast Enhanced MRI - HCC Lesions	79.8	± 12.9
Dynamic Contrast Enhanced MRI - Metastatic Lesions	72.2	± 20.4
Dynamic Contrast Enhanced MRI - Benign Lesions	73.6	± 15.9

Distribution Volume (DV) Primary · 1 day, At time of Research MRI

Dynamic Contrast Enhanced MRI data were used to calculate three quantitative perfusion properties using a dual input, single tissue compartment model of gadolinium based contrast agents in the liver in HCC, metastatic, and benign lesions. One of these quantitative perfusion properties is DV. DV corresponds to the volume of extracellular, extravascular space in a tissue which is a measure of the tissue cellularity

Group	Value	95% CI
Dynamic Contrast Enhanced MRI - HCC Lesions	29.9	± 13.0
Dynamic Contrast Enhanced MRI - Metastatic Lesions	53.8	± 19.3
Dynamic Contrast Enhanced MRI - Benign Lesions	61.8	± 20.9

Mean Transit Time (MTT) Primary · 1 day, At time of Research MRI

Dynamic Contrast Enhanced MRI data were used to calculate three quantitative perfusion properties using a dual input, single tissue compartment model of gadolinium based contrast agents in the liver in HCC, metastatic, and benign lesions. One of these quantitative perfusion properties is MTT. MTT corresponds to the average time, in seconds, that red blood cells spend within a determinate volume of capillary circulation

Group	Value	95% CI
Dynamic Contrast Enhanced MRI - HCC Lesions	12.0	± 3.1
Dynamic Contrast Enhanced MRI - Metastatic Lesions	44.6	± 25.7
Dynamic Contrast Enhanced MRI - Benign Lesions	5.8	± 2.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Within 48 hours of scan. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dynamic Contrast Enhanced MRI

Serious: 1/34 (3%)

Deaths: 0/34

Free-Breathing Quantification of Relaxation Parameters

Serious: 0/18 (0%)

Deaths: 0/18

Serious adverse events (1 terms)

Reaction	System	Dynamic Contrast Enhanced …	Free-Breathing Quantificat…
Chest pain	Cardiac disorders	—	—

Most-reported serious reactions: Chest pain.

Data from ClinicalTrials.gov NCT02095678 adverse events section.

Sponsor's own description

The primary objective of this study is to develop and validate simultaneous free-breathing 4D fat and water quantification and quantitative dynamic contrast enhanced perfusion in the liver. Secondary aims include developing and validating free breathing quantification of relaxation parameters T1 and T2, and developing and validating a minimal breath-hold (\< 8 s) high quality diffusion exam using highly accelerated steady state diffusion imaging sequences. Investigators aim to scan 100 subjects receiving liver biopsies as a part of their standard care and another 70 subjects with known benign lesions. The study is greater than minimal risk.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.