Trial Outcomes & Findings for Assessment of Novel MRI Quantification Free Breathing Technique in Evaluation of Liver Lesions (NCT NCT02095678)

NCT ID: NCT02095678

Last Updated: 2022-06-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

1 day, At time of Research MRI

Results posted on

2022-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	Dynamic Contrast Enhanced MRI 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. 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 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	Free-Breathing Quantification of Relaxation Parameters 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 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
Overall Study STARTED	34	18
Overall Study COMPLETED	17	0
Overall Study NOT COMPLETED	17	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Dynamic Contrast Enhanced MRI 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. 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 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	Free-Breathing Quantification of Relaxation Parameters 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 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
Overall Study Withdrawal by Subject	0	1
Overall Study Omitted for Severe Image Artifacts or Patient Non-compliance	11	12
Overall Study lesion impacted by previous treatment	1	1
Overall Study No Confirmed Diagnosis	0	3
Overall Study Malignant lesions not HCC nor Metastatic	1	1
Overall Study No Visible Lesion or Pathological Finding	4	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dynamic Contrast Enhanced MRI n=34 Participants 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. 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 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	Free-Breathing Quantification of Relaxation Parameters n=18 Participants 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 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	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=34 Participants	0 Participants n=18 Participants	0 Participants n=52 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=34 Participants	13 Participants n=18 Participants	31 Participants n=52 Participants
Age, Categorical >=65 years	16 Participants n=34 Participants	5 Participants n=18 Participants	21 Participants n=52 Participants
Sex: Female, Male Female	12 Participants n=34 Participants	5 Participants n=18 Participants	17 Participants n=52 Participants
Sex: Female, Male Male	22 Participants n=34 Participants	13 Participants n=18 Participants	35 Participants n=52 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	34 participants n=34 Participants	18 participants n=18 Participants	52 participants n=52 Participants
Lesion type HCC	10 Participants n=34 Participants	9 Participants n=18 Participants	19 Participants n=52 Participants
Lesion type Metastatic Cancer	16 Participants n=34 Participants	3 Participants n=18 Participants	19 Participants n=52 Participants
Lesion type Benign	3 Participants n=34 Participants	2 Participants n=18 Participants	5 Participants n=52 Participants
Lesion type No confirmed diagnosis, other malignant, or no visible lesion/path	5 Participants n=34 Participants	4 Participants n=18 Participants	9 Participants n=52 Participants

PRIMARY outcome

Timeframe: 1 day, At time of Research MRI

Population: 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.

Outcome measures

Outcome measures
Measure	Dynamic Contrast Enhanced MRI - HCC Lesions n=13 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. 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 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	Dynamic Contrast Enhanced MRI - Metastatic Lesions n=46 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. 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 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	Dynamic Contrast Enhanced MRI - Benign Lesions n=3 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. 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 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
Arterial Fraction	79.8 percentage of arterial fraction Standard Deviation 12.9	72.2 percentage of arterial fraction Standard Deviation 20.4	73.6 percentage of arterial fraction Standard Deviation 15.9

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Dynamic Contrast Enhanced MRI - HCC Lesions n=5 Participants 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. 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 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	Dynamic Contrast Enhanced MRI - Metastatic Lesions n=10 Participants 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. 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 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	Dynamic Contrast Enhanced MRI - Benign Lesions n=3 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. 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 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
Distribution Volume (DV)	29.9 percentage of DV Standard Deviation 13.0	53.8 percentage of DV Standard Deviation 19.3	61.8 percentage of DV Standard Deviation 20.9

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Dynamic Contrast Enhanced MRI - HCC Lesions n=13 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. 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 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	Dynamic Contrast Enhanced MRI - Metastatic Lesions n=46 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. 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 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	Dynamic Contrast Enhanced MRI - Benign Lesions n=3 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. 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 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
Mean Transit Time (MTT)	12.0 seconds Standard Deviation 3.1	44.6 seconds Standard Deviation 25.7	5.8 seconds Standard Deviation 2.0

SECONDARY outcome

Timeframe: Up to 1 year

Population: Quality of images were poor and could not be used for analysis

Quantified and validated relaxation parameters when creating T1 (spin-lattice) and T2 (spin-spin) weighted images

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Although the study team worked on the development of this technology as part of an NIH grant, this technology was not utilized as a part of this study so no data were collected.

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.

Outcome measures

Outcome data not reported

Adverse Events

Dynamic Contrast Enhanced MRI

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Free-Breathing Quantification of Relaxation Parameters

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dynamic Contrast Enhanced MRI n=34 participants at risk 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. 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 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	Free-Breathing Quantification of Relaxation Parameters n=18 participants at risk 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 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
Cardiac disorders Chest pain	2.9% 1/34 • Number of events 1 • Within 48 hours of scan	0.00% 0/18 • Within 48 hours of scan

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vikas Gulani

Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Phone: +1 216-844-3312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place