PET/CT dynamic scan,needle biopsy and gene detection

Positron-Emission Tomography

Carcinoma, Hepatocellular

The purpose of this study is to carry out 18F-FDG PET/CT dynamic scans and biopsy of primary or primary and metastatic lesions in newly diagnosed patients with primary liver cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of 18F-FDG PET/CT dynamic imaging in primary liver cancer metastases are discussed.

PET/CT dynamic scan

Hongjun Jin

Diagnostic Significance of Single Center, Open and Prospective Evaluation of <Sup>18<Sup>F-FDG PET/CT Dynamic Imaging and Genomic Sequencing in Detecting Metastatic Lesions of Primary Hepatocellular Carcinoma

For each patient enrolled in the study, a two-chamber four-parameter model (2TCM) and a Patlak two-parameter model are established using 18F-FDG PET/CT dynamic scans. Summarizing these dynamic model parameters for all enrolled patients separately calculates the overall diagnostic sensitivity and specificity. Calculate ROC based on sensitivity and specificity.

Summarize the genetic testing of all enrolled patients and radiomic indicators to calculate the overall diagnostic sensitivity and specificity. At the same time, the intrinsic correlations between genomics, gene detection and histopathology are summarized.

Principal Investigator

Fifth Affiliated Hospital, Sun Yat-Sen University

Device:
Niti-S Biliary ComVi Stent is a hollow cylindrical stent fabricated by knitting first and second super-elastic shape memory alloy wires to make a net-like structure. A plurality of interlocked points allow each of the inside and outside stent bodies to contract and expand in the longitudinal direction and to apply a force against the longitudinal contraction. A hollow polytetrafluoroethylene (PTFE) membrane tube is closely fitted between the inside and outside stent bodies, with each of overlapped ends of the PTFE membrane tube and the inside and outside stent bodies integrated into a single structure.

Device:
The Niti-S Stent (D-type) maintains a desired bent shape corresponding to the specific target lesion. It is comprised of a hollow cylindrical stent body fabricated by knitting first and second super-elastic shape memory alloy wires to make a net-like structure with a plurality of interlocked points capable of allowing the stent body to contract and expand in the longitudinal direction and to apply a force against the longitudinal contraction of the stent body.
The wires are made of a shape memory alloy through a process of shaping the alloy then heat-treating the wires to allow restoration of the original shape at a predetermined temperature.

Biliary Cancer

Endoscopic placement of biliary fully covered metal stents

Niti-S Biliary ComVi Stent

Endoscopic placement of biliary uncovered metal stent

Niti-S stent (D type)

General Hospital sanremo

Covered Versus Uncovered SEMS for Palliation of Malignant Biliary Strictures.

Covered Versus Uncovered Self-conformable Metal Stent for Palliation of Primary Malignant Extra-hepatic Biliary Strictures: a Randomized Multicenter Study

The Kaplan-Meier method will be used to estimate stent patency in each group and the log-rank test will be used for an unadjusted comparison between groups. Then a Cox proportional hazard model will be constructed to compare time to stent occlusion adjusted for important potential confounders. Stent patency will be calculated in days and will represent the interval between the time of stent insertion and the time of its replacement or the death of the patient with concomitant cholangitis.

Relationships between complication rates and stent type will be examined by the chi-square or the exact Fisher tests. Logistic regression will be used to compare stent complication rates adjusted for important potential confounders.

Health-related quality of life (HRQL) will be evaluated by a paired t-test to determine the impact of stent placement (i.e. compare baseline HRQL and month 3 HRQL) by Student's t -test to compare the differences in HRQL at baseline and 3 months between study groups. Linear regression models will be constructed to assess HQRL while adjusting for factors other than stent type.

For all analyses the Statistical Package for Social Sciences software (SPSS, Inc. for Windows will be used.

Total direct costs for each study group will be compared and cost effectiveness modelled.
For all analyses the Statistical Package for Social Sciences software (SPSS, Inc. for Windows) will be used.

MASSIMO CONIO

MD, Director of Gastroenterology Department, General Hospital Sanremo, Italy

Azienda USL 1 Imperiese

Ospedali Riuniti Marche Nord, Pesaro, Italy

NOCSAE Hospital, Modena, Italy

University of Siena, Italy

Papa Giovanni XXIII Hospital

This is a single-arm study. All subjects will take UDCA and ATRA.

Cholangitis, Sclerosing

The subjects will continue to take their current dose of UDCA (15 mg/kg/day), as per ongoing clinical care, and need to be on a stable dose of UDCA for at least six months prior to enrollment.
The specific intervention is the addition of daily oral ATRA (45 mg/m^2) divided into 2 doses. To increase adherence to the dosing regimen, the drug will be compounded by the Research Pharmacies of Yale and Mayo into 2 formulations (30 mg and 40 mg capsules), and an Investigational New Drug (IND) permit was obtained for this process.

Oral all-trans retinoic acid (ATRA)

Yale University School of Medicine - 333 Cedar St - 1080 LMP

Mayo Clinic

Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis

Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis - A Human Pilot Study

The primary outcome measure is a 30% improvement in serum alkaline phosphatase in subjects, comparing pre- and post-treatment values for each individual.

cholangiocarcinoma/phosphatase

Diagnostic Significance of Single Center, Open and Prospective Evaluation of ^{18^{F-FDG PET/CT Dynamic Imaging and Genomic Sequencing in Detecting Metastatic Lesions of Primary Hepatocellular Carcinoma}}

Covered Versus Uncovered SEMS for Palliation of Malignant Biliary Strictures.

Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis

Najbardziej kompletna baza danych ziół leczniczych poparta naukowo

cholangiocarcinoma/phosphatase

Diagnostic Significance of Single Center, Open and Prospective Evaluation of 18F-FDG PET/CT Dynamic Imaging and Genomic Sequencing in Detecting Metastatic Lesions of Primary Hepatocellular Carcinoma

Covered Versus Uncovered SEMS for Palliation of Malignant Biliary Strictures.

Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis

Najbardziej kompletna baza danych ziół leczniczych poparta naukowo

Diagnostic Significance of Single Center, Open and Prospective Evaluation of ^{18^{F-FDG PET/CT Dynamic Imaging and Genomic Sequencing in Detecting Metastatic Lesions of Primary Hepatocellular Carcinoma}}