Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Stomach Neoplasms

Carcinoma

Carcinoma, Hepatocellular

Esophageal Neoplasms

Rectal Neoplasms

Liver Diseases

Gastrointestinal Stromal Tumors

Liver Neoplasms

Duodenal Neoplasms

Neoplasms, Second Primary

Neoplastic Processes

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Stomach Cancer

Esophageal Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

Liver Transplantation

Felipe Alconchel, MD, PhD

Juan Ángel Fernández-Hernández, MD, PhD

Pablo Ramírez, MD, PhD

Jerónimo Martínez, MD, PhD

Francisco Sánchez-Bueno, MD, PhD

Ricardo Robles, MD, PhD

Liver Transplantation for Unresectable GIST Liver Metastases

Liver Transplantation in Patients With Unresectable GastroIntestinal Stromal Tumors (GIST) Liver Metastases

Hospital Universitario Virgen de la Arrixaca

MD, PhD, Principal Investigator

Cholangiocarcinoma

Biliary Tract Neoplasms

Biliary Tract Diseases

Bile Duct Cancer

Biliary Tract Cancer

Surgical waste tissue will be collected after removal of a liver tumor. A blood sample may be collected at the time of labs related to treatment for the diagnosis. An extra sample of biopsy tissue will be collected from participants having a targeted mass biopsy.

Surgical waste tissue will be collected after removal of a biliary tumor. A blood sample may be collected at the time of labs related to treatment for the diagnosis. An extra sample of biopsy tissue will be collected from participants having a targeted mass biopsy.

Tushar Patel

Tushar C Patel, MBChB

John A Copland, PhD

Patients having surgery to remove a liver or biliary tissue mass or having a biopsy of a mass or lesion will have a tissue sample collected and stored for future research of liver and biliary diseases. A blood sample may also be collected at the time of enrollment.

The study establishes a tissue and blood registry at Mayo Clinic Florida to support translational investigations into the biology, etiology and prognosis of liver and biliary masses such as through the use of patient-derived xenografts.

Patients having surgery to remove a liver or biliary mass or having a biopsy of a mass or lesion will be asked to donate a portion of the removed mass for research purposes. Only portions of the mass not required for clinical diagnostic evaluation, or surgical waste, will be used in this research study.

The tissues acquired will be stored and used for any specific, hypothesis driven protocols that are IRB approved. Serum and plasma samples may also be obtained at enrollment.

Clinical patient data from medical charts that may be correlative to outcomes will be collected and stored in a password secure data base. Data will be extracted from medical records charts.

Liver and Biliary Tumor Tissue Registry

Establishment of a Tissue and Blood Registry to Support Translational Investigations Into the Biology, Etiology and Therapy of Liver and Biliary Tumors

The number of successful individual patient derived xenografts that are established beyond the second passage in immunodeficient mice

Mayo Clinic

Consultant

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Renal Insufficiency

Comparison of Sonazoid enhanced ultrasound to non enhanced CT

Sonazoid

Patients with renal failure or other reason for contraindication for contrast enhanced computed tomography (CECT) or contrast enhanced magnetic resonance imaging (CEMRI) with suspected liver pathology will be evaluated with Sonazoid enhanced Ultrasound

Patients with a diagnosis of cancer or high probability of cancer (any primary) who have contraindications for a contrast enhanced Computed Tomography or Magnetic Resonance Image will be asked to participate in this study. Patients will be both male and female and be \>18 years old. Contraindications for computer tomography (CT) or magnetic resonance imaging (MRI) would include, but not limited to:

1. Creatinine clearance of \<60 mg/dl
2. Allergy to iodinated contrast or gadolinium based contrast agents
3. History of adverse event with CT or MRI contrast

Up to 100 patients will be enrolled over a two year period.

Statistical justification for sample size Assuming that a non-enhanced CT will detect and characterize metastatic disease correctly 60% of the time (2) and that Contrast enhanced ultrasound (CEUS) will detect and characterize metastatic disease correctly 90% of the time (3,4), there will be a 100% chance of a significant difference at a one-sided 0.05 significance level using the Fisher Exact Test.

CT and MRI Patient will receive the non-contrast CT or MRI that would be ordered as routine stating or follow-up of the patient. At a minimum 5mm contiguous axial slices will be obtained with CT and T1-weighted, T2-weighted, in-phase and out of phase imaging will be performed on MRI with a minimum slice thickness of 5mm. Each lesion noted within the liver will be measured in two dimensions and recorded. The lesion will be classified on a scale of 1 - 5 regarding the probability of benignity or malignancy of the lesion. If a diagnosis can be made the diagnosis will be documented The location of the lesion will be documented on a Couinaud diagram.

CEUS-Contrast specific software optimized for Sonazoid will be used or both vascular and Kupffer phase imaging. The focus will be set below the lesion of interest for vascular phase imaging and at 4-8 cm for the left lobe and 8-10 cm for the right lobe for Kupffer phase imaging. The lesion of interest was imaged from 15 seconds before injection to 1 minute after injection (vascular phase imaging). No further scanning will be performed until the Kupffer phase imaging, which will begun 10 minutes after the injection.

The patient will receive the following ultrasound imaging:

1. Standard B-mode and color-Doppler imaging. Elastography may be added at PI's discretion.
2. A 20g IV will be placed in an antecubital vein
3. Low MI scan will be used in the vascular phase.
4. An intermediate MI scan will be used after at least a 10 minute delay to perform the Kupffer scan
5. If a lesion is identified on the Kupffer scan which is not characterized by the without exam the patient will have a complete evaluation of the vascular phase a second injection may be used.

Each lesion noted within the liver will be measured in two dimensions and recorded. The lesion will be classified on a scale of 1 - 5 regarding the probability of benignity or malignancy of the lesion. If a diagnosis can be made the diagnosis will be documented. The location of the lesion will be documented on a Couinaud Diagram.

The gold standard will be either

1. characteristic enhancement pattern (hemangioma, benign)
2. lesion biopsy
3. growth of the lesion over a 6 month period of time (malignant)

Data Analysis

For assessment of characterization efficacy the McNemar test will be used to compare the rates of correct diagnosis for lesions on unenhanced ultrasound, CEUS and unenhanced CT or MRI. For assessment of detection efficacy, Wilcoxon's signed rank test will be used to compare the lesion detection rates obtained with unenhanced ultrasound, CEUS, and unenhanced CT or MRI. For all tests, p\<0.05 will be considered a statistically significant difference.

Evaluation of Suspected Liver Pathology in Patients With Contraindications for Contrast Enhanced CT and/or MRI

Evaluation of Suspected Liver Pathology in Patients With Contraindications for Contrast Enhanced Computed Tomography and/or Magnetic Resonance Imaging Using Sonazoid

Determination of the liver lesion detection rate of Sonozoid

Determine the accuracy of liver lesion characterization by Sonozoid

Evaluate the Adverse event rate using Sonozoid

Northeastern Ohio Radiology Research and Education Fund

Medical Director

Infections

Hepatitis A

Hepatitis

Liver Cirrhosis

Fibrosis

Blood samples will be collected at entry into the study and at varying intervals over a two to three year period.

Blood samples will be collected at entry into the system and at varying intervals over a two to three year period.

Blood samples will be collected during regular intervals over a three year period.

A single blood sample will be collected at entry into the study

Blood samples collected at varying intervals over a two to three year period.

Blood samples

Tushar Patel, MBChB

The study will examine and evaluate the use of extracellular RNA in blood as markers for the diagnosis of liver disease or cancer, and as markers for prediction of response to treatment or recurrence of cancer after surgery

The goal is to identify an extracellular RNA candidate for the detection and diagnosis of liver cancers such as hepatocellular cancer or biliary cancer, and chronic liver diseases. The use of selected exRNA biomarkers for diagnosis of hepatocellular cancer (HCC) or biliary tract cancers in patients with cirrhosis will be evaluated in a prospective case-control study. The study will create a registry of patients who have chronic liver disease, cirrhosis, liver and biliary tract cancers. A risk factor questionnaire will be administered to facilitate identification of risk factors for development of liver cancer. Patient information will be obtained from the medical record, and include demographics, medical history, liver disease, smoking and alcohol history, etiology, family history, and clinical laboratory data.

Extracellular RNA Markers of Liver Disease and Cancer

The exRNA biomarker levels in the HCC and biliary tract cancer groups will be evaluated and compared to the exRNA biomarker levels present in the case-control groups, cirrhosis and chronic liver disease. Statistical analysis will be used to evaluate the sensitivity and specificity of these markers for the diagnosis of cancers based on findings of liver mass, imaging characteristics, size, and extent of viable tumor on imaging, or on elevated levels of tumor markers such as alphafetoprotein.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Liver Transplantation for Unresectable GIST Liver Metastases	NCT04825470	Liver Diseases Liver Cancer Liver Metastase... Liver Neoplasms Liver Mass Liver Carcinoma Liver Transplan... Liver Transplan... GIST GIST, Malignant Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Metastases to L... Metastatic Live... Metastasis Metastases Liver Transplan... Transplant Onco...	Liver Transplan...	18 Years -	Hospital Universitario Virgen de la Arrixaca
Liver Transplantation for Unresectable GIST Liver Metastases	NCT04825470	Liver Diseases Liver Cancer Liver Metastase... Liver Neoplasms Liver Mass Liver Carcinoma Liver Transplan... Liver Transplan... GIST GIST, Malignant Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Metastases to L... Metastatic Live... Metastasis Metastases Liver Transplan... Transplant Onco...	Liver Transplan...	18 Years -	Hospital Universitario Virgen de la Arrixaca
Liver and Biliary Tumor Tissue Registry	NCT02917759	Hepatocellular ... Cholangiocarcin...		18 Years -	Mayo Clinic
Evaluation of Suspected Liver Pathology in Patients With Contraindications for Contrast Enhanced CT and/or MRI	NCT02651090	Liver Metastasi... Liver Mass	Sonazoid	18 Years - 100 Years	Northeastern Ohio Radiology Research and Education Fund
Liver and Biliary Tumor Tissue Registry	NCT02917759	Hepatocellular ... Cholangiocarcin...		18 Years -	Mayo Clinic
Extracellular RNA Markers of Liver Disease and Cancer	NCT02908048	Hepatocellular ... Biliary Tract C... Cirrhosis Liver Diseases	Blood samples	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for liver mass

Every month we try and update this database with for liver mass cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for liver mass

Every month we try and update this database with for liver mass cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for liver mass cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.