(13C-Methacetin(University of Texas Southwestern Medical Center))

概要

基本信息

药物类型

化学药、诊断用放射药物

别名

N-(4-Methoxy-13C-phenyl)acetamide

靶点-

作用机制

PET imaging(正电子发射断层成像术增强剂)

治疗领域

消化系统疾病其他疾病感染+ [2]

在研适应症-

非在研适应症

急性肺损伤药物性肝损伤并发症+ [9]

原研机构

University of Texas Medical Branch

在研机构-

非在研机构

Meridian Bioscience Israel Ltd.

Meridian Bioscience, Inc.

Hadassah University Hospital

+ [1]

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

关联

4

项与 13C-Methacetin(University of Texas Southwestern Medical Center) 相关的临床试验

NCT03611101 / CompletedN/A

Companion Protocol for the ¹³C-Methacetin Breath Test (MBT) for Use in Bristol-Myers Squibb Phase 2b Studies for BMS-986036 (PEG-FGF21), Under Studies Referenced in NCT03486899, NCT03486912

This is a companion study assessing the ¹³C-Methacetin Breath Test (MBT) in subjects participating in the Bristol Myers-Squibb (BMS) NCT03486899 and NCT03486912 referenced studies using study drug BMS-986036.

开始日期2018-05-04

申办/合作机构

Meridian Bioscience, Inc.

[+1]

NCT02786836 / Completed临床2/3期IIT

13C-Methacetin Breath Test for the Prediction of Outcome in in Acute Liver Injury or Acute Liver Failure

The ALFSG-MBT protocol is for a multicenter, open label, non-randomized study to determine the value of Breath Identification® (BreathID®) N-(4-Methoxy-13C-phenyl)acetamide (13C-Methacetin) Breath Test System in predicting the outcome of patients diagnosed with severe acute liver injury that is not related to acetaminophen overdose or acute liver failure who meet inclusion/exclusion criteria.
Up to 200 evaluable patients will be enrolled. An evaluable patient is one who has completed one or more breath tests for at least 30 minutes after administration of the 13C-Methacetin solution (test substrate).
The Breath Test will be performed up to five times during the study period on all enrolled patients. The first Breath Test will be performed upon admission into the study (Day 1) and repeated on Days 2, 3, 5 and 7 provided no contra-indications are present. Each test continuously measures changes in the metabolism of the 13C-Methacetin in order to assess the improvement or deterioration in liver metabolic function about improvement or deterioration in liver metabolic function. If an enrolled non-APAP ALI or ALF patient receives a liver transplant, is discharged /transferred from the hospital or dies prior to Day 7, additional Breath Tests will not be performed.
Patients will be contacted for the Day 21 follow up (21 days after enrollment into the trial) to determine spontaneous survival, transplantation and occurrence of serious adverse events since the patient's last study treatment.

开始日期2016-06-10

申办/合作机构

The University of Texas Southwestern Medical Center

[+4]

EUCTR2014-002037-59-ES / Not yet recruiting临床3期

Clinical Study of the BreathID® LF System to train the algorithm for the ¹³C-Methacetin Breath Test (MBT) in assessment of Portal Hypertension in Patients with Compensated Liver Cirrhosis - Protocol Number: CSPH-EX-0414

开始日期2015-04-01

申办/合作机构-

100 项与 13C-Methacetin(University of Texas Southwestern Medical Center) 相关的临床结果

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100 项与 13C-Methacetin(University of Texas Southwestern Medical Center) 相关的转化医学

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100 项与 13C-Methacetin(University of Texas Southwestern Medical Center) 相关的专利（医药）

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26

项与 13C-Methacetin(University of Texas Southwestern Medical Center) 相关的文献（医药）

2022-01-01·Dose-response : a publication of International Hormesis Society4区 · 医学

The Potential Protective Effect of Curcumin and α-Lipoic Acid on N-(4-Hydroxyphenyl) Acetamide-induced Hepatotoxicity Through Downregulation of α-SMA and Collagen III Expression

4区 · 医学

ArticleOA

作者: Ali, Hanaa ; Badr, Amira ; Fadda, Laila ; Sarawi, Wedad ; Mahamad, Raeesa ; Alhusain, Ahlam ; Hasan, Iman ; Alomar, Hatun

Background and objectives:

N-(4-hydroxyphenyl) acetamide (NHPA) is the most commonly used analgesic and antipyretic agent worldwide; however, it remains the leading cause of drug-induced acute liver failure. This study explored the potential impact of curcumin (Curc) and/or α-lipoic acid (Lip acid) on liver damage induced by NHPA overdose.

Materials and Methods:

Male Wistar rats were intoxicated with a single oral dose of NHPA (1000 mg/kg) and treated with Curc (200 mg/kg p. o.) and/or Lip acid (100 mg/kg i. p.). These treatments were given in 2 doses at 2 hours and 10 hours post-NHPA-administration. Animals were sacrificed 24 hours post-NHPA-administration.

Results:

Treatment with Curc and/or Lip acid showed effective reduction of NHPA-induced liver injury, demonstrated by reducing serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, as well as hepatic nitric oxide and malondialdehyde. Curc and/or Lip acid treatments counteracted these changes. They also ameliorated NHPA-induced centrilobular hepatocellular necrosis, evidenced by histopathological examination. Moreover, Curc and Lip acid reduced the expression of alpha-smooth muscle actin and collagen III, upregulated by NHPA intoxication in response to oxidative stress and inflammation.

Discussion and Conclusion:

Curc and Lip acid can be considered as promising natural therapies against liver injury, induced by NHPA, through their antioxidant and antifibrotic actions.

2018-09-01·European radiology2区 · 医学

Gd-EOB-DTPA-enhanced T1 relaxometry for assessment of liver function determined by real-time 13C-methacetin breath test

2区 · 医学

Article

作者: Poelsterl, Stefanie ; Fuhrmann, Irene ; Stroszczynski, Christian ; Nickel, Marcel D ; Verloh, Niklas ; Wiggermann, Philipp ; Fellner, Claudia ; Dahlke, Marc H ; Weigand, Kilian ; Haimerl, Michael

OBJECTIVES:

To determine whether liver function as determined by intravenous administration of ¹³C-methacetin and continuous real-time breath analysis can be estimated quantitatively from gadoxetic acid (Gd-EOB-DTPA)-enhanced magnetic resonance (MR) relaxometry.

METHODS:

Sixty-six patients underwent a ¹³C-methacetin breath test (¹³C-MBT) for evaluation of liver function and Gd-EOB-DTPA-enhanced T1-relaxometry at 3 T. A transverse 3D VIBE sequence with an inline T1 calculation based on variable flip angles was acquired prior to (T1 pre) and 20 min post-Gd-EOB-DTPA (T1 post) administration. The reduction rate of T1 relaxation time (rrT1) and T1 relaxation velocity index (∆R1) between pre- and post-contrast images was evaluated. ¹³C-MBT values were correlated with T1_post, ∆R1 and rrT1, providing an MRI-based estimated ¹³C-MBT value. The interobserver reliability was assessed by determining the intraclass correlation coefficient (ICC).

RESULTS:

Stratified by three different categories of ¹³C-MBT readouts, there was a constant increase of T1 post with increasing progression of diminished liver function (p ≤ 0.030) and a constant significant decrease of ∆R1 (p ≤ 0.025) and rrT1 (p < 0.018) with progression of liver damage as assessed by ¹³C-methacetin breath analysis. ICC for all T1 relaxation values and indices was excellent (> 0.88). A simple regression model showed a log-linear correlation of ¹³C-MBT values with T1_post (r = 0.57; p < 0.001), ∆R1 (r = 0.59; p < 0.001) and rrT1 (r = 0.70; p < 0.001).

CONCLUSION:

Liver function as determined using real-time ¹³C-methacetin breath analysis can be estimated quantitatively from Gd-EOB-DTPA-enhanced MR relaxometry.

KEY POINTS:

• Gd-EOB-DTPA-enhanced T1 relaxometry quantifies liver function • Gd-EOB-DTPA-enhanced MR relaxometry may provide parameters for assessing liver function before surgery • Gd-EOB-DTPA-enhanced MR relaxometry may be useful for monitoring liver disease progression • Gd-EOB-DTPA-enhanced MR relaxometry has the potential to become a novel liver function index.

2015-01-01·The Journal of surgical research4区 · 医学

Reliable assessment of liver function using LiMAx

4区 · 医学

Article

作者: Jara, Maximilian ; Malinowski, Maciej ; Valle, Erika ; Schulz, Antje ; Lock, Johan Friso ; Stockmann, Martin ; Jung, Tobias ; Seehofer, Daniel ; Bednarsch, Jan

BACKGROUND:

(13)C-liver function breath tests can facilitate the assessment of hepatic function in-vivo and may help surgeons to identify candidates for safe liver surgery. However, their acceptance into clinical practice is dependent on evaluation of technical efficacy and repeatability. The aims of this study were to evaluate the within-subject repeatability of the LiMAx (maximum liver function capacity) test in healthy individuals and in surgical patients to determine liver function in the perioperative workup.

MATERIAL AND METHODS:

The LiMAx test, which is based on intravenous injection of (13)C-methacetin at a dosage of 2 mg/kg body weight was performed in eighty-six healthy subjects to determine a reference range. Twenty-four subjects underwent repeat LiMAx testing the following day to assess within-subject repeatability. Twenty-one patients undergoing elective extra-abdominal surgery under general anesthesia (GA group) received pre- and post-operative examinations.

RESULTS:

The normal range of LiMAx was found to be 430 ± 86 μg/kg/h and revealed a one-sided cut-off value of 315 μg/kg/h. The intraclass correlation coefficient of the repeat LiMAx tests was 0.85 (95% confidence interval 0.69-0.93) in the control group and 0.81 (95% confidence interval 0.60-0.92) in the group of patients with GA.

CONCLUSIONS:

The LiMAx test shows excellent reproducibility in subjects with normal liver function. GA has no effect on test results.

100 项与 13C-Methacetin(University of Texas Southwestern Medical Center) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性肺损伤	临床3期	美国	Meridian Bioscience, Inc.	2016-06-10
药物性肝损伤	临床3期	美国	Meridian Bioscience, Inc.	2016-06-10
急性肝功能衰竭	临床3期	美国	Meridian Bioscience, Inc.	2016-06-10
慢性阻塞性肺疾病	临床3期	以色列	Meridian Bioscience Israel Ltd.	2010-09-30
慢性乙型肝炎	临床3期	以色列	Hadassah University Hospital	2010-09-17
肝功能衰竭	临床3期	美国	Meridian Bioscience Israel Ltd.	2010-03-31
肝功能衰竭	临床3期	以色列	Meridian Bioscience Israel Ltd.	2010-03-31
纤维化	临床3期	美国	Meridian Bioscience Israel Ltd.	2008-08-31
纤维化	临床3期	以色列	Meridian Bioscience Israel Ltd.	2008-08-31
并发症	临床2期	美国	Meridian Bioscience Israel Ltd.	2015-03-31

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03611101 (CTgov)	N/A	非酒精性脂肪性肝炎	124	BreathID MCS device+BMS-986036+¹³C-Methacetin Breath Test	願構鹽簾鹽鑰淵遞壓遞(遞艱淵餘觸襯觸顧製網) = 膚壓蓋淵蓋夢齋顧遞鏇壓憲襯糧窪獵襯鬱製積 (淵鹹簾鹽積糧繭壓構鏇, 鹽鏇壓壓範襯膚鏇醖鑰 ~ 蓋艱構範淵構齋壓繭鑰) 更多	-	2022-08-09
NCT02786836 (CTgov)	临床2/3期	急性肺损伤 \| 药物性肝损伤 \| 急性肝功能衰竭	76	13C-Methacetin	鏇壓糧遞選觸製築餘願(網蓋積夢觸餘鬱壓窪膚) = 壓糧壓鏇簾積鹹夢獵積餘膚築艱廠夢衊艱願糧 (蓋遞衊鬱鑰獵製糧鹽憲, 鑰廠廠鏇築範構鹹蓋壓 ~ 淵餘窪鬱遞蓋醖鑰蓋衊) 更多	-	2020-12-22
EASL2020	N/A	肝功能衰竭	15	13C-methacetin	糧鹽鬱遞憲憲膚構廠鹽(構餘觸壓淵夢網窪壓積) = 顧淵淵鑰製齋顧蓋簾遞廠選窪構蓋積襯蓋憲選 (範遞獵淵醖選醖夢齋膚, 753 ~ 61)	-	2020-08-27