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

Primary Purpose

Hepatocellular Carcinoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

liver biopsy

free-breathing MRI

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult, HCC

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

No contraindications to getting contrast enhanced MRI examinations.
GFR ≥ 40.

Exclusion Criteria:

Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
The presence of an implanted pacemaker or implanted defibrillator device
Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient.
Pregnancy. Regular clinical practice already excludes pregnant patients from gadolinium contrast due to unknown effects on the fetus. The current clinical practice will be applied - patients will be verbally screened and asked if they think they could be pregnant. If the answer is yes, then the patient will be excluded from the study. If the patient is uncertain about the pregnancy status, she will be given an option to undergo a pregnancy test or not participate in the study altogether. Patients who self report that they are not pregnant will be allowed to participate in the study. This procedure is based on current department policy guidelines.
Implanted medical device not described above that is not MRI-compatible;
Known history of claustrophobia;
Known history of allergic reaction to Magnetic Resonance contrast material;
Late stage renal failure with estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 based on patient's serum creatinine due to the significantly increased risk of nephrogenic systemic fibrosis (NSF). ('Past' 3 months timeframe will be used to calculate the eGRF).
Minors will be excluded.
Prisoners and members of other vulnerable populations will be excluded from this study. The subject selection population will not regularly include prisoners and other vulnerable population members as these populations will not provide any additional unique information to or uniquely benefit from the study. Non-english speaking population will be excluded from the study due to lack of sufficient resources to pay for translator and interpreter services.

Sites / Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HCC or metastatic Liver Lesions

Benign Liver Lesion

Arm Description

Patients with HCC or metastatic liver lesions who are refered to the abdominal imaging and biopsy clinic will have a liver biopsy performed. 3-5 days after a clinical MRI indicating a cancerous lesion, patients will return for the free-breathing MRI and a liver biopsy. These images will be compared to the clinical MRI and to images of the benign lesions.

Patients with benign liver lesions will be referred to the study team. 3-5 days after a clinical MRI an experimental, free-breathing MRI will be performed on these patients. The results will be compared to their clinical MRI images and to images of HCC or metastatic lesions

Outcomes

Primary Outcome Measures

Arterial Fraction

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.

Distribution Volume (DV)

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

Mean Transit Time (MTT)

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

Secondary Outcome Measures

Free Breathing Quantification of Relaxation Parameters

Quantified and validated relaxation parameters when creating T1 (spin-lattice) and T2 (spin-spin) weighted images

Minimal Breathhold Time

The minimum time (in seconds) a patient must hold their breath to produce quality liver images during an MRI. Developing and validating a minimal breath-hold (< 8 s) high quality diffusion exam using highly accelerated steady state diffusion imaging sequences.

Full Information

NCT ID

NCT02095678

First Posted

March 20, 2014

Last Updated

June 29, 2022

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02095678

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

December 1, 2013 (undefined)

Primary Completion Date

December 3, 2019 (Actual)

Study Completion Date

December 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

The investigators hypothesize that a quantitative and near free-breathing MRI approach with Hepatocellular carcinoma (HCC) patients will lead to improved tissue characterization, resulting in fewer ambiguous readings and thus fewer biopsies. As each component of the proposed methodology has been experimentally validated in the investigators preliminary work, the next appropriate step would be to evaluate the clinical feasibility of the exam. The investigators goal is to test the ability of quantitative MRI techniques to provide high quality images of the liver and to differentiate liver lesions from one another in a time frame shorter than a current clinical exam.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult, HCC

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HCC or metastatic Liver Lesions

Arm Type

Experimental

Arm Description

Arm Title

Benign Liver Lesion

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

liver biopsy

Intervention Description

patients with HCC or metastatic lesions will have a liver biopsy performed after the experimental MRI. This biopsy will be examined to confirm the imaging results

Intervention Type

Device

Intervention Name(s)

free-breathing MRI

Other Intervention Name(s)

experimental MRI

Intervention Description

All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality

Primary Outcome Measure Information:

Title

Arterial Fraction

Description

Time Frame

1 day, At time of Research MRI

Title

Distribution Volume (DV)

Description

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

Time Frame

1 day, At time of Research MRI

Title

Mean Transit Time (MTT)

Description

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

Time Frame

1 day, At time of Research MRI

Secondary Outcome Measure Information:

Title

Free Breathing Quantification of Relaxation Parameters

Description

Quantified and validated relaxation parameters when creating T1 (spin-lattice) and T2 (spin-spin) weighted images

Time Frame

Up to 1 year

Title

Minimal Breathhold Time

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: No contraindications to getting contrast enhanced MRI examinations. GFR ≥ 40. Exclusion Criteria: Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips. The presence of an implanted pacemaker or implanted defibrillator device Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient. Pregnancy. Regular clinical practice already excludes pregnant patients from gadolinium contrast due to unknown effects on the fetus. The current clinical practice will be applied - patients will be verbally screened and asked if they think they could be pregnant. If the answer is yes, then the patient will be excluded from the study. If the patient is uncertain about the pregnancy status, she will be given an option to undergo a pregnancy test or not participate in the study altogether. Patients who self report that they are not pregnant will be allowed to participate in the study. This procedure is based on current department policy guidelines. Implanted medical device not described above that is not MRI-compatible; Known history of claustrophobia; Known history of allergic reaction to Magnetic Resonance contrast material; Late stage renal failure with estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 based on patient's serum creatinine due to the significantly increased risk of nephrogenic systemic fibrosis (NSF). ('Past' 3 months timeframe will be used to calculate the eGRF). Minors will be excluded. Prisoners and members of other vulnerable populations will be excluded from this study. The subject selection population will not regularly include prisoners and other vulnerable population members as these populations will not provide any additional unique information to or uniquely benefit from the study. Non-english speaking population will be excluded from the study due to lack of sufficient resources to pay for translator and interpreter services.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vikas Gulani, MD

Organizational Affiliation

Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29563601

Citation

Pahwa S, Liu H, Chen Y, Dastmalchian S, O'Connor G, Lu Z, Badve C, Yu A, Wright K, Chalian H, Rao S, Fu C, Vallines I, Griswold M, Seiberlich N, Zeng M, Gulani V. Quantitative perfusion imaging of neoplastic liver lesions: A multi-institution study. Sci Rep. 2018 Mar 21;8(1):4990. doi: 10.1038/s41598-018-20726-1.

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

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