Assessment of Novel MRI Quantification Free Breathing Technique in Evaluation of Liver Lesions
2022년 6월 29일 업데이트: Case Comprehensive Cancer Center
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
52
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ohio
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Cleveland, Ohio, 미국, 44106
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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
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
다른 이름들:
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활성 비교기: 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
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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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Arterial Fraction
기간: 1 day, At time of Research MRI
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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. |
1 day, At time of Research MRI
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Distribution Volume (DV)
기간: 1 day, At time of Research MRI
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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 |
1 day, At time of Research MRI
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Mean Transit Time (MTT)
기간: 1 day, At time of Research MRI
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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 |
1 day, At time of Research MRI
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Free Breathing Quantification of Relaxation Parameters
기간: Up to 1 year
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Quantified and validated relaxation parameters when creating T1 (spin-lattice) and T2 (spin-spin) weighted images
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Up to 1 year
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Minimal Breathhold Time
기간: 1 year
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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.
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1 year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Vikas Gulani, MD, Case Comprehensive Cancer Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2013년 12월 1일
기본 완료 (실제)
2019년 12월 3일
연구 완료 (실제)
2019년 12월 3일
연구 등록 날짜
최초 제출
2014년 3월 20일
QC 기준을 충족하는 최초 제출
2014년 3월 24일
처음 게시됨 (추정)
2014년 3월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 6월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 6월 29일
마지막으로 확인됨
2022년 6월 1일
추가 정보
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