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



Status:Recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:1/10/2019
Start Date:December 1, 2013
End Date:August 2019
Contact:Vikas Gulani, MD
Email:Vikas.Gulani@Uhhospitals.org
Phone:216-844-3312

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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.

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.

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.
We found this trial at
1
site
11100 Euclid Avenue
Cleveland, Ohio 44106
Principal Investigator: Vikas Gulani, MD
Phone: 216-844-3312
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mi
from
Cleveland, OH
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