Liver function assessment with three<sup>13</sup>C breath tests by two-point measurements

Ishii, Yoshinori; Suzuki, Shigeru; Asai, Satoshi; Murai, Ichirou

doi:10.1080/10256016.2012.682991

Cited by 7 publications

(2 citation statements)

References 65 publications

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“…From the first description of 13 C-MeBT [33] until now, the studies carried out in different countriesincluding the one reported here-have consistently shown the usefulness of 13 C-MeBT as an alternative for the noninvasive assessment of the functional activity of the liver in patients with different stages of liver disease [15,18,[32][33][34][35][36][37][38][39][40][41][42][43][44][45]; however, this test has not been used specifically to predict mortality in decompensated patients.…”

Section: Discussionmentioning

confidence: 98%

The utility of the ¹³ C-methacetin breath test in predicting the long-term survival of patients with decompensated cirrhosis

et al. 2017

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One hundred and twenty-three patients were included. A significant inverse correlation was found between delta over baseline at the 15 min point (DOB) after ingestion of C-methacetin and the Child-Pugh score (r = -0.411, p< 0.001). In multivariate analysis, DOB ≤ 4.5‰ was associated with mortality, [HR = 2.58 95% CI (1.17-5.69)]. In conclusion, our results confirm the utility of C-MeBT as a simple, noninvasive tool to quantitatively assess the liver's functional reserve and as a potential predictor of long-term survival in patients with decompensated cirrhosis.

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Section: Discussionmentioning

confidence: 98%

The utility of the ¹³ C-methacetin breath test in predicting the long-term survival of patients with decompensated cirrhosis

et al. 2017

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“…The [ 13 C]-MBT has been extensively researched for evaluating CYP1A2 enzyme activity and to evaluate quantitative liver function [32][33][34][35][36][37][38][39][40][41][42]. Methacetin is primarily O-demethylated by the CYP1A2 enzyme in the liver to acetaminophen and the breath biomarker 13 CO 2 .…”

Section: Methacetin-[ 13 ]C Breath Test (Mbt)mentioning

confidence: 99%

Regulatory issues on breath tests and updates of recent advances on [¹³C]-breath tests

Modak

2013

J. Breath Res.

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Over the last decade non invasive diagnostic phenotype [(13)C]-breath tests as well as tests using endogenous volatile organic compounds (VOCs) in breath have been researched extensively. However, only three breath tests have been approved by the FDA over the last 15 years. Despite the potential benefits of these companion diagnostic tests (CDx) for evaluation of drug metabolizing enzyme activities and standalone diagnostic tests for disease diagnosis to personalize medicine, the clinical and commercial development of breath tests will need to overcome a number of regulatory, financial and scientific hurdles prior to their acceptance into routine clinical practice. The regulatory agencies (FDA and EMEA) need to adapt and harmonize their approval process for companion diagnostic tests as well as standalone diagnostic breath tests for personalized medicine. The Center for Devices and Radiological Health has deemed any breath test that involves a labeled (13)C substrate/drug and a device requires a Pre Market Approval (PMA), which is analogous to an approved New Drug Application. A PMA is in effect, a private license granted to the applicant for marketing a particular medical device. Any breath test with endogenous VOCs along with a device can be approved via the 510(k) application. A number of (13)C breath tests with clinical applications have been researched recently and results have been published in reputed journals. Diagnostic companies will need to invest the necessary financial resources to develop and get regulatory approval for diagnostic breath tests capable of identifying responders/non responders for FDA approved drugs with narrow therapeutic indices (personalized medicine) or for evaluating the activity of drug metabolizing P450 polymorphic enzymes or for diagnosing diseases at an early stage or for monitoring the efficacy of medications. The financial success of these diagnostic breath tests will then depend entirely on how the test is marketed to physicians, healthcare organizations, payers (reimbursement), insurance companies and most importantly to patients, the eventual beneficiaries.

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Intestinal mucosal proliferation, apoptosis and oxidative stress in patients with liver cirrhosis

Assimakopoulos

Tsamandas²,

Tsiaoussis

et al. 2013

Annals of Hepatology

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Liver function assessment with three¹³C breath tests by two-point measurements

Cited by 7 publications

References 65 publications

The utility of the ¹³ C-methacetin breath test in predicting the long-term survival of patients with decompensated cirrhosis

The utility of the ¹³ C-methacetin breath test in predicting the long-term survival of patients with decompensated cirrhosis

Regulatory issues on breath tests and updates of recent advances on [¹³C]-breath tests

Intestinal mucosal proliferation, apoptosis and oxidative stress in patients with liver cirrhosis

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Liver function assessment with three13C breath tests by two-point measurements

Cited by 7 publications

References 65 publications

The utility of the 13 C-methacetin breath test in predicting the long-term survival of patients with decompensated cirrhosis

The utility of the 13 C-methacetin breath test in predicting the long-term survival of patients with decompensated cirrhosis

Regulatory issues on breath tests and updates of recent advances on [13C]-breath tests

Intestinal mucosal proliferation, apoptosis and oxidative stress in patients with liver cirrhosis

Contact Info

Product

Resources

About

Liver function assessment with three¹³C breath tests by two-point measurements

The utility of the ¹³ C-methacetin breath test in predicting the long-term survival of patients with decompensated cirrhosis

The utility of the ¹³ C-methacetin breath test in predicting the long-term survival of patients with decompensated cirrhosis

Regulatory issues on breath tests and updates of recent advances on [¹³C]-breath tests