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Patients who will undergo resection of at least two hepatic segments for HCC or radiofrequency ablation (RFA) for HCC and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI

Potential liver donors with normal hepatic function and and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI

1. Gd-EOB-DTPA enhanced MRI will be obtained within 1 week before, and within 3 to 5 days after surgical resection of the liver.
2. Gd-EOB-DTPA will be administered intravenously with an amount of 0.1mL/kg, 1mL/sec injection rate, followed by saline infusion.

Gd-EOB-DTPA

1. Gd-EOB-DTPA enhanced MRI will be performed within 3 days of obtaining ICG R15 test.
2. Gd-EOB-DTPA will be administered intravenously with an amount of 0.1mL/kg, 1mL/sec injection rate, followed by saline infusion.

1. Gd-EOB-DTPA enhanced MRI will be obtained within 1 week before, and within 3 to 5 days after surgical resection of the liver.
2. Multiphasic MRI including dynamic hepatocyte specific phase will be performed for evaluation of hepatic extraction fraction, with 25 phase dynamic MRI obtained until 30 minutes after contrast injection.

1. Gd-EOB-DTPA enhanced MRI will be performed within 3 days of obtaining ICG R15 test.
2. Multiphasic MRI including dynamic hepatocyte specific phase will be performed for evaluation of hepatic extraction fraction, with 25 phase dynamic MRI obtained until 30 minutes after contrast injection.

Jeong Min Lee, MD, PhD

The purpose of this study is to determine whether the global and segmental hepatic uptake and excretion of Gd-EOB-DTPA on Gd-EOB-DTPA-enhanced liver MRI correlates with standard liver function test results in the patients with Hepatocellular Carcinoma (HCC) before major hepatic resection or radiofrequency ablation (RFA).

1. Preoperative/RFA assessment of remnant liver function is important for avoiding posthepatectomy liver failure. However, the function of the future remnant is decreased in patients with chronic liver disease or cirrhosis, compared to that of healthy patients with an equal volume. Therefore, volume-based estimation of hepatic reserve function is inadequate for patients with hepatic dysfunction.
2. Standard clinical liver function tests, such as ICG clearance rate or Child-Pugh score, provides measurements of the global hepatic function, but cannot evaluate the functional distribution in the liver. Gd-EOB-DTPA (Gadoxetic acid, Primovist®, Bayer Schering) enhanced MRI has been recently demonstrated to have the potential to be an imaging-based liver function test, with the possibility to detect functional differences on a regional or even segmental level.
3. Gd-EOB-DTPA-enhanced liver MRI may be able to assess not only global but also segmental liver function in patients with hepatocellular carcinoma (HCC) who have a relatively high risk for developing liver failure after surgical resection due to coexistent hepatic damage by chronic viral hepatitis and/or cirrhosis preoperatively.

The purpose of this study is to determine whether the global and segmental hepatic uptake and excretion of Gd-EOB-DTPA on Gd-EOB-DTPA-enhanced liver MRI correlates with standard liver function test results in the patients with HCC before major hepatic resection/RFA.

Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma

Pre-Surgical Treatment or Radio Frequency Ablation (RFA) Evaluation of Future Remnant Liver Function Using Gd-EOB-DTPA Enhanced MRI in Patients Undergoing Hepatic Resection /RFA for Hepatocellular Carcinoma

Predicted RLF (HEF mL) = the sum of the individual HEF of each voxel in future remnant segment

1. Functional parameters derived from Gd-EOB-DTPA enhanced MRI include hepatic extraction fraction \[HEF\], input-relative blood flow \[irBF\], hepatocellular uptake index \[HUI\], liver to spleen ratio (LSR).
2. Volumetric parameters include global liver volume and remnant liver volume.
3. Clinical liver function tests include ICG R15, MELD score and Child-Pugh score.
4. ICG R15 \[Indocyanine green retention at 15 minutes, %\] test will be performed within 3 days of preoperative MRI and 3 days after surgical resection.

1. Clinical parameters refer to the following.

   * Frequency of POD#5 days 50-50 criteria
   * Evaluation of operation related complication
   * Incidence of hepatic failure or death
2. Functional and volumetric MRI parameters of patients with postoperative complication and morbidity will be evaluated.
3. Correlation of MRI parameters with laboratory liver function tests.

1. Correlation of functional parameters derived from Gd-EOB-DTPA enhanced MRI with ICG R15
2. Correlation of functional and volumetric parameters derived from Gd-EOB-DTPA enhanced MRI
3. Correlation of volumetric parameters derived from Gd-EOB-DTPA enhanced MRI and ICG15
4. Comparison of functional MRI parameters between potential liver donors and patients undergoing hepatic resection for HCC.

Bayer

Seoul St. Mary's Hospital

Asan Medical Center

Chonnam National University Hospital

Seoul National University Hospital

Associate Professor

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metformin, exenatide or combined (metformin & exenatide )

Karen E Elkind-Hirsch, Ph.D.

Rajat Bhushan, M.D.

Current research has shown that the use of diabetes management practices aimed at reducing insulin resistance and hyperinsulinemia (such as weight reduction and the administration of oral antidiabetic drugs) in women with PCOS can not only improve glucose and lipid metabolism but can also reverse testosterone abnormalities and restore menstrual cycles. A new medicine called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal glucose metabolism in diabetics. This randomized study will compare Exenatide (Byetta) to extended release metformin (Fortamet) to combination therapy (both Byetta and Fortamet) on menstrual cyclicity, hormone profiles and metabolic profiles over a 24-week period in women with PCOS.

Objectives: The objective of the present proposal is to compare the clinical, endocrine and metabolic effects of therapy with exenatide and metformin alone, to combination therapy in women with PCOS. This study will serve as a pilot investigation to open perspectives for future investigations combining insulin-sensitizing drugs with different mechanisms of action in patients with PCOS, especially ones for whom standard treatment with metformin is less effective.

Subjects : 60 oligomenorrheic overweight/obese (BMI \>27) women meeting criteria for PCOS (age 18-40)· six or fewer menses /year or amenorrheic· clinical or laboratory evidence of hyperandrogenism (hirsutism or elevated testosterone (T))· PCOS ovary on ultrasound(need to meet criteria 1 and either 2 or 3 \[or both\]) Inclusion/Exclusion Criteria: Major EXCLUSION CRITERIA - FEMALE1) other uncorrected endocrinopathy- hyperprolactinemia, hyper- or hypothyroidism, congenital adrenal hyperplasia2) presence of overt diabetes or impaired glucose tolerance3) alterations in hepatic or renal function4) use of hormonal medications, insulin sensitizers or medications that interfere with carbohydrate metabolism for at least 8 weeks5) Any medical condition which, in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug6) Simultaneous participation in another clinical trial7) Known active substance abuse including tobacco and alcohol. (\> 10 cigarettes/day)8) Refusal or inability to comply with protocol9) patient desiring pregnancy, pregnant, or breastfeeding Study Design: Balanced randomized parallel group clinical study with 3 treatment arms: metformin (1000 mg BID); exenatide (10 mcg BID) or combined (metformin 1000 mg BID; exenatide 10 mcg BID) therapy for 24 weeks.

Efficacy Measures: Primary- Menstrual Cyclicity ( # menses/ 24 weeks)Secondary-BMI, WHR, FAI (T/SHBG), DHEAS, lipids, insulin resistance-(HOMA and composite insulin sensitivity index \[ SIOGTT), and pancreatic ß-cell function (corrected insulin response \[CIRgp\] and insulinogenic index \[IGI\] ).

Safety: For safety, all subjects who enter the study are evaluable. Subjects will be monitored for safety by assessment of adverse events, physical exams, vital signs and laboratory values.

Statistical methods/analysis: The measurement of menstrual frequency involves nominal data ( patients with/without regular cycles pre vs post-treatment and will be analyzed using the McNemar test (complex chi square for paired data). For all other analyses, in which the data are interval, parameters, such as androgens, lipids, insulin sensitivity, etc. will be evaluated using a SS/Treatment x Trials (pre/post) analyses of variance (ANOVA). This repeated measures design will allow us to determine if each of the treatment drugs had an effect and if they are significantly different from each other while controlling for individual patient differences Study Drug Regimens: Exenatide5 ug bid - 4 weeks10 ug bid - 20 weeks (end of study)Metformin500 mg qd 2 weeks500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks1000 mg bid -18 weeks (end study) Exenatide plus MetforminExenatide- 5 ug bid-4 weeksMetformin 500 qd for 2 weeks, 500 mg bid 2 weeksExenatide- 10 ug -20 weeks (to end of study)Metformin-500 mg am, 1000 mg pm- 2 weeks - 1000 bid for 18 weeks (end of study)\*\* Metformin may be adjusted at the discretion of the physician to a level that is tolerable in patients who cannot tolerate the full dose of metformin in combination with exenatide (combination therapy only )

Exenatide and Metformin Therapy in Overweight Women With PCOS

Comparison of the Effects of Monotherapy With Exenatide or Metformin to Combined Exenatide and Metformin Therapy on Menstrual Cyclicity in Overweight Women With Polycystic Ovary Syndrome

Amylin Pharmaceuticals, LLC.

Metabolic Center of Louisiana Research Foundation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma	NCT01490203	Carcinoma, Hepa... Liver Dysfuncti...	Gd-EOB-DTPA Gd-EOB-DTPA MRI MRI	18 Years -	Seoul National University Hospital
Exenatide and Metformin Therapy in Overweight Women With PCOS	NCT00344851	Polycystic Ovar...	metformin, exen...	18 Years - 40 Years	Metabolic Center of Louisiana Research Foundation

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