Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05792423 |
| Other study ID # |
2022P003180 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 30, 2023 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Massachusetts General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to assess possible bioeffects that may be caused by the use of shear wave
elastography (SWE) with conditionally increased acoustic output pressure (CIO). Bioeffects
will be monitored by of a series of liver function tests (LFTs) with results graded according
to the NCI scale for drug hepatoxicity. LFTs will be collected prior to SWE imaging using
CIO, as well up to 7 days post-imaging. Secondarily, this study aims to understand the degree
to which SWE imaging results have improved with the use of COI.
Description:
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in
the United States, with an estimated prevalence of approximately 30%. NAFLD is a disease with
a spectrum that can be categorized as 1) simple steatosis/non-alcoholic fatty liver, defined
as excess liver fat without inflammation, and 2) non-alcoholic steatohepatitis (NASH) in
which excess liver fat is associated with inflammation, fibrosis, and healing, ultimately
culminating in cirrhosis. Nonalcoholic steatohepatitis (NASH) can progress to conditions
associated with high morbidity and mortality such as portal hypertension, cirrhosis, liver
failure and hepatocellular carcinoma. NASH is currently the second most common indication for
liver transplantation in the United States, and is expected to become the leading cause in
the near future.
Liver biopsy is currently accepted as the gold-standard method to detect liver fibrosis,
though it is an invasive procedure with high morbidity and mortality rates. Alternatively,
imaging is useful for NAFLD diagnosis, disease management, and monitoring treatment response.
Several imaging methods are used for these purposes, including ultrasound, MRI, and CT based
techniques. Ultrasound (US) is preferred by many physicians because it is a low-cost
technique that is widely available. Shear wave elastography (SWE) is an ultrasound-based
technique that is commonly used for liver fibrosis staging. When performing ultrasound
imaging, it is known that several patient-related factors may influence the quality of the
image.
In NAFLD patients, several factors including high skin-to-liver capsule distance (SCD) may
change the attenuation and aberration of the acoustic waves, change the quality of the image,
and make diagnosis harder for radiologists. SCD is the distance between skin and Glisson's
capsule, when assessed with standard B-mode ultrasound imaging. In patients with high SCD,
and particularly in patients with abdominal obesity, the shear wave elasticity elastogram box
may not fill properly, which may cause unreliable SWE measurements. Technical failure and
unreliable SWE measurements have been previously reported.
The current FDA guidelines recommend the use of a maximum derated spatial peak temporal
average intensity (ISPTA) of ≤ 720 mW/cm2, and either the maximum MI should be ≤ 1.9 or the
maximum derated spatial peak pulse average intensity (ISPPA) should be ≤ 190 W/cm2. In
addition, clinical justification is required if the TI exceeds 6. Several diagnostic modes
that are clinically used and FDA approved use acoustic output values that approach these
maximum guidelines. These diagnostic modes include acoustic radiation force impulse (ARFI)
based techniques, harmonic imaging techniques, and Doppler based techniques. In the past
decade, the AIUM has published reports on the benefits and limitations of both the TI and MI,
including recommendations that transient increases may be warranted if there were associated
clinical benefit.
Using the acoustic and thermal limits in current FDA guidelines, it is not always possible to
get reliable SWE measurements. Therefore, conditionally increasing the acoustic pressure of a
SWE system may help clinicians to obtain reliable and accurate SWE results from patients with
abdominal obesity, potentially minimizing the need for liver biopsy.
This study aims to assess possible bioeffects that may be caused by the use of SWE with
conditionally increased acoustic output pressure (CIO). Bioeffects will be monitored by of a
series of liver function tests (LFTs) with results graded according to the NCI scale for drug
hepatoxicity. LFTs will be collected prior to SWE imaging using CIO, as well up to 7 days
post-imaging. Secondarily, this study aims to understand the degree to which SWE imaging
results have improved with the use of COI.
