Hepatocellular CarcinomaNCT02095678

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

A study testing liver biopsy and free-breathing MRI in people with Hepatocellular Carcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Hepatocellular Carcinoma
What is being tested?: liver biopsy and free-breathing MRI
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2013to 3 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

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.

Read the 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.

Conditions: Hepatocellular Carcinoma
Being tested: liver biopsy, free-breathing MRI
Keywords: Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult, HCC
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

liver biopsyProcedure or surgery
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
free-breathing MRIDevice
Also called experimental MRI
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

Study groups in NCT02095678
Study group	Role	What they receive
HCC or metastatic Liver Lesions	Experimental	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. Receives: Procedure: liver biopsy; Device: free-breathing MRI
Benign Liver Lesion	Active comparator	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 Receives: Device: free-breathing MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 day, At time of Research MRI
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
Measured: 1 day, At time of Research MRI
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
Measured: 1 day, At time of Research MRI

Secondary outcomes (2)

Free Breathing Quantification of Relaxation Parameters
Quantified and validated relaxation parameters when creating T1 (spin-lattice) and T2 (spin-spin) weighted images
Measured: Up to 1 year
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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20133 Dec 2019

First posted26 Mar 2014 (estimated)
Study start1 Dec 2013
Primary completion3 Dec 2019
Study completion3 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02095678
Sponsor's protocol ID: CASE3213
Status last verified: Jun 2022
First submitted: 20 Mar 2014
Last updated: 30 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 29563601

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatocellular Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Novel MRI Quantification Free Breathing Technique in Evaluation of Liver Lesions
ClinicalTrials.gov ID: NCT02095678
Acronym / sponsor ID: CASE3213
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult, HCC
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Case Comprehensive Cancer CenterUniversity, hospital or other
Study start: 1 Dec 2013
Primary completion: 3 Dec 2019 (actual)
Study completion: 3 Dec 2019 (actual)
First posted: 26 Mar 2014 (estimated)
Results: Posted 11 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
HCC or metastatic Liver Lesions	Experimental	Procedure: liver biopsy, Device: free-breathing MRIPatients 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.
Benign Liver Lesion	Active comparator	Device: free-breathing MRIPatients 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

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
liver biopsypatients 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	Procedure or surgery	HCC or metastatic Liver Lesions
free-breathing MRIAlso: experimental MRIAll 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	Device	Benign Liver Lesion, HCC or metastatic Liver Lesions

Primary outcome

Arterial Fraction
Time frame: 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.
Distribution Volume (DV)
Time frame: 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
Mean Transit Time (MTT)
Time frame: 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

2 secondary outcomes

Free Breathing Quantification of Relaxation Parameters
Time frame: Up to 1 year
Minimal Breathhold Time
Time frame: 1 year

Results and safety

Results posted to the registry on 11 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dynamic Contrast Enhanced MRI	34	17
Free-Breathing Quantification of Relaxation Parameters	18	0

Primary outcome: Arterial Fraction

Time frame: 1 day, At time of Research MRI. Mean (Standard Deviation). Unit: percentage of arterial fraction

Measure	Dynamic Contrast Enhanced MRI - HCC Lesions n = 5	Dynamic Contrast Enhanced MRI - Metastatic Lesions n = 10	Dynamic Contrast Enhanced MRI - Benign Lesions n = 2
Value	79.8 (12.9)	72.2 (20.4)	73.6 (15.9)

Dynamic Contrast Enhanced MRI - HCC Lesions vs Dynamic Contrast Enhanced MRI - Metastatic Lesions: p = 0.211, t-test, 2 sided

Population analysed: Evaluable participants (those who completed study with applicable lesions). Note - There were only sufficient number of participants to statistically compare HCC and Metastatic lesion groups due to the low number of benign lesions. No data are available for the "Free-breathing Quantification of Relaxation Parameters" for reasons listed in participant flow section - primarily relating to image blurring and artifacts.

Primary outcome: Distribution Volume (DV)

Time frame: 1 day, At time of Research MRI. Mean (Standard Deviation). Unit: percentage of DV

Measure	Dynamic Contrast Enhanced MRI - HCC Lesions n = 5	Dynamic Contrast Enhanced MRI - Metastatic Lesions n = 10	Dynamic Contrast Enhanced MRI - Benign Lesions n = 2
Value	29.9 (13.0)	53.8 (19.3)	61.8 (20.9)

Dynamic Contrast Enhanced MRI - HCC Lesions vs Dynamic Contrast Enhanced MRI - Metastatic Lesions: p <0.01, t-test, 2 sided

Primary outcome: Mean Transit Time (MTT)

Time frame: 1 day, At time of Research MRI. Mean (Standard Deviation). Unit: seconds

Measure	Dynamic Contrast Enhanced MRI - HCC Lesions n = 5	Dynamic Contrast Enhanced MRI - Metastatic Lesions n = 10	Dynamic Contrast Enhanced MRI - Benign Lesions n = 2
Value	12.0 (3.1)	44.6 (25.7)	5.8 (2.0)

Dynamic Contrast Enhanced MRI - HCC Lesions vs Dynamic Contrast Enhanced MRI - Metastatic Lesions: p <0.01, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Within 48 hours of scan. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dynamic Contrast Enhanced MRI	1 of 34 (2.9%)	0 of 34 (0%)	0 of 34
Free-Breathing Quantification of Relaxation Parameters	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Limitations and caveats (from the sponsor): Free breathing quantification of T1 and T2 was explored and initial tests were run as part of this study. However, free-breathing acquisition of data yielded substantial image blurring, making it impossible to accurately delineate and characterize lesions. Several technical improvements were implemented, but improved image quality was not achieved. Dynamic Contrast Enhanced MRI data from this study combined with data from a second institution were published in Nature Scientific Reports in 2018

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29563601Pahwa 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vikas Gulani, MD principal investigator

Case Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing liver biopsy and free-breathing MRI in people with Hepatocellular Carcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arterial Fraction (time frame: 1 day, At time of Research MRI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02095678, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.