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

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ClinicalTrials.gov Identifier: NCT02095678
Recruitment Status : Recruiting
First Posted : March 26, 2014
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: liver biopsy Device: free-breathing MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Novel MRI Quantification Free Breathing Technique in Evaluation of Liver Lesions
Study Start Date : December 1, 2013
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: HCC or metastatic Liver Lesions
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.
Procedure: liver biopsy
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

Device: free-breathing 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
Other Name: experimental MRI

Active Comparator: Benign Liver Lesion
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
Device: free-breathing 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
Other Name: experimental MRI




Primary Outcome Measures :
  1. Metastases vs. Benign Lesion Agreement [ Time Frame: 1 year from IRB approval of study ]
    The statistical difference in classification of lesion images using a clinical MRI and the free-breathing MRI when compared to diagnosis by biopsy sample. The agreement between the clinical MRI-based diagnosis and true diagnosis will be calculated using a McNemar test for correlated proportions.

  2. HCC vs. Benign Lesion Agreement [ Time Frame: 1 year from IRB approval of study ]
    The statistical difference in classification of lesion images using a clinical MRI and the free-breathing MRI when compared to diagnosis by biopsy sample. The agreement between the clinical MRI-based diagnosis and true diagnosis will be calculated using a McNemar test for correlated proportions.

  3. HCC vs. Metastases Lesion agreement [ Time Frame: 1 year from IRB approval of study ]
    The statistical difference in classification of lesion images using a clinical MRI and the free-breathing MRI when compared to diagnosis by biopsy sample. The agreement between the clinical MRI-based diagnosis and true diagnosis will be calculated using a McNemar test for correlated proportions.


Secondary Outcome Measures :
  1. Free breathing quantification of relaxation parameters [ Time Frame: 1 year from IRB approval of study ]
    Quantified and validated relaxation parameters when creating T1 (spin-lattice) and T2 (spin-spin) weighted images

  2. Minimal Breathhold time [ Time Frame: 1 year from IRB approval of study ]
    The minimum time (in seconds) a patient must hold their breath to produce quality liver images during an MRI.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095678


Contacts
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Contact: Vikas Gulani, MD 216-844-3312 Vikas.Gulani@Uhhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Vikas Gulani, MD    216-844-3312    Vikas.Gulani@Uhhospitals.org   
Principal Investigator: Vikas Gulani, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Vikas Gulani, MD Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02095678     History of Changes
Other Study ID Numbers: CASE3213
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Case Comprehensive Cancer Center:
Hepatocellular Carcinoma
Hepatoma
Liver Cancer, Adult
Liver Cell Carcinoma
Liver Cell Carcinoma, Adult
HCC
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics