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

Bile Duct Cancer

Amino Acids

Fluorides

Fluorodeoxyglucose F18

Radiopharmaceuticals

Protective Agents

Glutamic Acid

Patients undergo an 18F-FSPG PET scan within 4 weeks of surgery or OLT. Patients may also receive a second 18F-FSPG PET scan following standard-of-care treatment.

Patients may undergo either carbon-11 (11C)-Acetate PET or 18F-FDG PET scans within 4 weeks of surgery or OLT.

Fluorine F 18 L-glutamate Derivative 18F-FSPG

Carbon C 11 Acetate

Undergo 18F-FSPG, 11C-acetate, or 18F-FDG PET

Positron Emission Tomography

Laboratory Biomarker Analysis

Fluorine F 18 2-deoxy-2-(18F)fluoro-D-glucose

Lesley Flynt, MD

This clinical trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET) in imaging patients with liver cancer before undergoing surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose liver cancer and find out how far the disease has spread.

PRIMARY OBJECTIVES:

I. To evaluate the relationship between 18F-FSPG PET/computed tomography (CT), pathology, and cancer metabolism in patients with suspected hepatocellular carcinoma (HCC) scheduled for liver resection surgery and orthotopic liver transplant (OLT).

II. To compare 18F-FSPG PET/CT with standard-of-care (SOC) diagnostic MRI imaging in patients with suspected HCC scheduled for liver resection surgery or OLT.

III. To compare the uptake of 18F-FSPG PET/CT with 11C-acetate PET/CT AND 18F-FDG PET/CT in suspected HCC and background liver in patients scheduled for liver resection surgery or OLT.

IV. To evaluate uptake of 18F-FSPG PET/CT in benign liver lesions compared to background.

V. To evaluate uptake of 18F-FSPG PET/CT in malignant non-HCC liver tumors.

OUTLINE:

Patients undergo 18F-FSPG PET and either carbon-11 (11C)-acetate PET or 18F-FDG PET scans within 4 weeks of surgery or OLT.

Cohorts A and B are Parallel. Cohorts C and D are Single Group. Cohorts E and F Single Group

18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant

PET Imaging of Hepatocellular Carcinoma With 18F-FSPG

The Standardized Uptake Value (SUV) for 18F-FSPG PET images will be determined in the hepatocellular carcinoma (HCC) tumor lesions, non-HCC liver tumors (benign), and background liver (normal tissue). These metrics include SUVmax, SUVpeak, or SUVmean and are common PET imaging measures.

The Standardized Uptake Value (SUV) for 11C-acetate PET images will be determined in the tumor lesions and background liver (normal tissue). These metrics include SUVmax, SUVpeak, or SUVmean and are common PET imaging measures.

The Standardized Uptake Value (SUV) for 18F-FDG PET images will be determined in the hepatocellular carcinoma (HCC) tumor lesions and background liver (normal tissue). These metrics include SUVmax, SUVpeak, or SUVmean and are common PET imaging measures.

The pharmacokinetics of 18F-FSPG, 11C-acetate and 18F-FDG uptake will be determined using compartmental modeling of PET imaging data. Venous samples will be collected over the course of 18F-FSPG, 11C-acetate and 18F-FDG scans to confirm blood pool radioactivity, evaluate metabolism, and to calibrate image-derived input functions. We will also utilize blood samples collected prior to scanning to assay plasma levels of carbon-12 acetate and glucose in each patient to explore normalizing pharmacokinetic parameters across patients.

The number of lesions detected by 18F-FSPG PET will be determined and compared to the number of lesions detected by standard-of-care MRI, 11C-acetate PET, or 18F-FDG PET on a per patient basis.

Sensitivity is defined as the true positive rate. It is defined as true positive/(true positive + false negative). The determination of HCC status will be based on diagnostic pathology.

Specificity is defined as the true negative rate. It is defined as true negative/(true negative + false positive). The determination of HCC status will be based on diagnostic pathology.

Tissue samples will be obtained for patients following either liver resection surgery or orthotopic liver transplant. Pathology will be performed on these tumor tissues as the gold-standard assessment to confirm the presence of HCC tumor. Histology will be correlated to PET imaging data.

Tissue samples will be obtained for patients following either liver resection surgery or orthotopic liver transplant. Tumor grade will be determined from pathology of tissue samples and correlated to PET imaging data for 18F-FSPG, 11C-acetate and 18F-FDG PET. The concordance of 18F-FSPG PET/CT and 11C-acetate PET/CT or 18F-FSPG PET/CT and 18F-FDG PET/CT will be evaluated. This will determine whether 18F-FSPG can be used singularly in place of combined use of 11C-acetate PET/CT (which typically detects low grade HCC) and 18F-FDG PET/CT (which typically detects high grade HCC).

Tissue samples will be obtained for patients following liver resection surgery. The expression of immunohistochemical markers (ie. xC- and CD44) will be evaluated in these tumor tissues on an ordinal scale of 0, 1, 2 or 3 and correlated to 18F-FSPG PET imaging data. In addition, markers of inflammation and immune cell recruitment (ie. CD86, CD163, CD3), proliferation (Ki67), and apoptosis (Caspase 3) will also be evaluated and correlated to 18F-FSPG PET imaging data.

HCC tumor and non-cancerous liver tissue samples will be obtained for patients following liver resection surgery. Overall, tumoral tissue, peritumoral tissue and grossly normal surrounding liver will be evaluated. Metabolic profiles will be analyzed by mass spectrometry. The unbiased metabolomic phenome will be determined and correlated to 18F-FSPG PET.

Milan criteria will be applied to standard-of-care (SOC) MRI images. The number and size of lesions will be determined. A patient will be deemed to meet Milan criteria if they exhibit A) A single lesion 2 to 5 cm in diameter or B) Three or fewer tumors, each measuring 1 to 3 cm in diameter, and C) No evidence of extrahepatic involvement or microvascular invasion. The proportion of patients whose Milan classification by novel imaging classification changed following validation by histological confirmation will be determined.

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
18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant	NCT02379377	Adult Hepatocel... Resectable Hepa... Cholangiocarcin... Benign Liver Tu... Metastases to L...	Fluorine F 18 L... Carbon C 11 Ace... Positron Emissi... Laboratory Biom... Fluorine F 18 2...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for metastases to liver