All patients with a suspicion of pancreatic masses will undergo EUS (including EUS-FNA for confirmation of diagnosis). A positive cytological diagnosis will be taken as a final proof of malignancy of the pancreas mass. The diagnoses obtained by EUS-FNA will be further verified during a clinical follow-up of at least 6 months.
Both pancreatic adenocarcinomas and pancreatic neuroendocrine tumors will be included.
Endoscopic ultrasound (including fine needle aspiration for confirmation of diagnosis) with sequential contrast-enhanced endoscopic ultrasound and elastography endoscopic ultrasound and contrast-enhanced computed tomography will be performed before and 2 months after the first course of treatment

Pancreas Cancer

EUS will be performed before (including EUS-FNA for confirmation of diagnosis) and 2 months after the first course of treatment.
Protocol of EUS with EUS-FNA should include linear EUS instruments with complete examinations of the pancreas.
Tumor characteristics (echogenicity, echostructure, size) will be described as well as presence/absence of power Doppler signals.
EUS-FNA will be performed in all pancreatic masses with at least four passes.

Endoscopic ultrasound (including fine needle aspiration)

CE-EUS will be performed during usual EUS examination before and 2 months after the first course of chemotherapy.
The starting point of the timer will be considered the moment of intravenous contrast injection (Sonovue 4.8 mL).
The whole movie (T0-T120s) will be recorded in a DICOM format on the embedded HDD of the ultrasound system, for later analysis.
All post-processing and computer analysis of digital movies will be performed within the coordinating IT Center using Vue-Box

Contrast-enhanced endoscopic ultrasound (CE-EUS)

EUS-EG will be performed during usual EUS examinations, before and 2-months after the first course of chemotherapy, with two movies of 10 seconds recorded on the embedded HDD
The region of interest for EUS-EG will be preferably larger than the focal mass. If the focal mass is larger than 3 cm, part of the mass will be included in the ROI, as well as the surrounding structures. Very large ROI for the elastography calculations will be avoided
The following pre-settings will be used in all centers: elastography color map 1, frame rejection 2, noise rejection 2, persistence 3, dynamic rage 4, smoothing 2, blend 50%.
SR and SH will be measured; with three measurements made and recorded on the embedded HDD.

Endoscopic ultrasound elastography (EG-EUS)

Contrast-enhanced computed tomography will be obtained before treatment to assess the local extension of the tumor, and presence of lymph nodes and distant metastases.
A template will be used to report the imaging results.
The template includes morphologic, arterial, venous, and extrapancreatic evaluations.
Contrast-enhanced computed tomography will be performed 2 months after the first course of chemotherapy, using the same template, in order to evaluate the tumor response. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST).

Contrast-enhanced computed tomography (CT)

Perfusion Assessment With Contrast-Enhanced EUS in Locally Advanced and Metastatic Pancreatic Cancer

Changes in Tumor Vascularity Depicted by Contrast-Enhanced Endoscopic Ultrasonography as a Predictor of Treatment Efficacy in Patients With Locally Advanced and Metastatic Pancreatic Cancer (PEACE)

PE represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

Wi-AUC represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

RT represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

mTT represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

TTP represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

Wir represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

WiPI represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

The overall survival (OS) will be measured from the first day of chemotherapy to the date of death

The progression-free survival (PFS) will be measured from the first day of chemotherapy to the date of progressive disease.

Contrast-enhanced computed tomography will be performed 2 months after the first course of chemotherapy in order to evaluate the tumor response.
Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). According to RECIST guidelines,complete response (CR) is defined as the complete disappearance of the tumor, partial response (PR) as ≥30% decrease in longest diameter (LD), progressive disease (PD) as ≥20% increase in LD, and stable disease (SD) as a decrease or increase less than PR or PD based on anatomic assessment. Patients with CR or PR will be defined as responders, whereas those with PD or SD are defined as non-responders.

University of Medicine and Pharmacy Craiova

Copenhagen University Hospital at Herlev

Iuliu Hatieganu University of Medicine and Pharmacy

Central Military Hospital Bucharest

Ponderas Regina Maria Hospital Bucharest

Caritas-Krankenhaus Bad Mergentheim

Helios Kliniken Meiningen

University of Santiago de Compostela

Hospital Märkisch Oderland Wriezen/ Strausberg

Institut Paoli-Calmettes

Ospedale San Raffaele

University College London Hospitals

Newcastle-upon-Tyne Hospitals NHS Trust

M.D. Anderson Cancer Center

Shengjing Hospital

Asan Medical Center

Tokyo Medical University

Singapore General Hospital

Malignant Neoplasm

Cancer

Fasting Mimicking Diet (or FMD) consists in a 5-day plant-based, low-calorie (600 Kcal on day 1, followed by 300 KCal/day on days 2 to 5), low-protein, low carbohydrate diet

Fasting mimicking diet

Fondazione IRCCS Istituto Nazionale dei Tumori

Safety, Feasibility and Metabolic Effects of the Fasting Mimicking Diet (FMD) in Cancer Patients

Safety is assessed by recording each adverse (AE) occurring during the period on diet. All AEs will be graded according to the NCI CTCAE v 4.03. Serious adverse events (SAEs) will be also reported.

Feasibility is defined as the ability of the patient to comply with the prescribed dietary regimen. It will be assessed through the analysis of food diaries filled by patients during the five days of each FMD cycle.

FMD-induced metabolic changes will be evaluated by measuring blood metabolites (glucose, cholesterol, triglycerides) and urinary ketone bodies before and at the completion of each FMD cycle.

FMD-induced changes in blood growth factors will be evaluated by measuring modifications of plasma insulin and serun insulin-like growth factor 1 (IGF-1) concentration before and at the completion of each FMD cycle

Percent changes in body weight will be measured during each FMD cycle and across subsequent FMD cycles.

FMD-induced changes in parameters linked to kidney function, such as blood urea nitrogen, creatinine and uric acid.

FMD-induced changes in parameters linked to liver function, such as aspartate and alanine transaminases, total bilirubin.

Filippo de Braud

Dean of Medical Oncology and Hematology Department

University of Milan

Patients with hypoglycemia after gastric bypass

Patients without hypoglycemia after gastric bypass

Hypoglycemia

68Ga-NODAGA-exendin-4 PET/CT

Rijnstate hospital

Radboudumc

GLP1R-imaging in Hypoglycemia

Visualizing Beta Cells in Patients With Hyperinsulinemic Hypoglycemia After Bariatric Surgery

Calculating uptake by quantitative image analysis

Correlate tracer uptake with C-peptide and HbA1c in patients

Radboud University

Rijnstate Hospital

Comparison of patients with hypoglycemia to control patients

This cohort includes patients who will receive chemotherapy at any stage or their treatment.

This cohort includes patients who will receive radiation therapy at any stage or their treatment.

This cohort includes patients who will undergo resection of the primary tumor.

Blood sample draw (50 ml or 3-4 tablespoons)

neuroendocrine tumors/carbohydrate

Perfusion Assessment With Contrast-Enhanced EUS in Locally Advanced and Metastatic Pancreatic Cancer

Safety, Feasibility and Metabolic Effects of the Fasting Mimicking Diet (FMD) in Cancer Patients

GLP1R-imaging in Hypoglycemia

Changes in Biomarkers From Blood Over Time in Patients With Pancreatic Adenocarcinoma

Cea mai completă bază de date cu plante medicinale susținută de știință