Clinical trial NCT02095678: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Hepatoma
Liver Cancer, Adult
Liver Cell Carcinoma
Liver Cell Carcinoma, Adult
HCC
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Arterial Fraction
timeFrame: 1 day, At time of Research MRI
measure: Distribution Volume (DV)
timeFrame: 1 day, At time of Research MRI
measure: Mean Transit Time (MTT)
timeFrame: 1 day, At time of Research MRI
Secondary outcomes:
measure: Free Breathing Quantification of Relaxation Parameters
timeFrame: Up to 1 year
measure: Minimal Breathhold Time
timeFrame: 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Vikas Gulani, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.