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Pancrelipase

Pancreatin

patients with resectable pancreas adenocarcinoma or neuroendocrine tumor underwent perfusion CT after intravenous iopromide administration

Patients with locally advanced pancreas cancer underwent perfusion CT after intravenous iopromide administration before and after chemotherapy.

1. iopromide (370mgI/mL) enhanced perfusion CT will be performed within 14 days of operation.
2. In patients who are planned to receive chemotherapy, iopromide enhanced perfusion CT was performed twice; within 14 days before starting 1st cycle and within 14 days after finishing 2nd cycle.
3. iopromide (370mgI/mL) will be administered intravenously with an amount of 30mL (body weight\[BW\] \<50kg) or 35 mL (50kg ≤BW \<70kg) or 40 mL (70 kg≤BW \<90kg) or 50 mL (90≤BW), followed by saline infusion (30mL).
4. Injection rate is as follows; 6.0mL/sec if BW is \<50kg, 7.0 mL/sec if BW is 50kg≤and \<70kg, 8.0 mL/sec if BW is 70≤and\<90kg and 9.0mL/sec if BW is 90kg≤.

iopromide

1. Perfusion CT will be performed by using a 320 channel MDCT
2. Patients are requested for fasting for at least 8 hours before CT scan.
3. Patients are requested for doing shallow breathing as slow as possible and wide strap is applied during CT scan.
4. Scan range is limited to the whole pancreas and it focuses to the pancreas tumor lesion.
5. During perfusion CT, 19 phases (ten phases with two seconds interval and six phases with three seconds interval and three phases with five seconds interval) are obtained in fifty three seconds.
6. ADIR 3D and SURE EXPOSURE 3D are applied during perfusion CT to minimize radiation dose.

Jeong Min Lee, MD, PhD

The purpose of this study is

1. to determine whether the perfusion parameters in the normal pancreas and the pancreas cancer (adenocarcinoma or neuroendocrine tumor) are different on perfusion CT
2. to determine whether initial perfusion parameters as well as perfusion parameter change in pancreas adenocarcinoma before and after chemotherapy are different between chemotherapy response group (CR, PR according to RECIST 1.1) and non response group (SD, PD according to RECIST 1.1).

1. Performance of preoperative perfusion CT for preoperative staging is assessed by comparing with operative finding and histologic disease staging
2. Estimation of initial or change of pancreas cancer perfusion parameters and whether those can provide cut-off value for predicting response of chemotherapy in patients with pancreas adenocarcinoma

Role of Perfusion CT in Pancreatic Cancer

Evaluation of Diagnostic Efficacy of Perfusion CT Using Wide Detector for Staging and Response Prediction After Chemotherapy in Pancreatic Cancer

Initial perfusion parameters (blood volume, blood flow and permeability) are compared between CTx-responder and non-responders after 6 cycle of the scheduled chemotherapy, using RECIST 1.1 criteria.

Perfusion parameters (blood volume, blood flow, and permeability) change between initial perfusion CT and second perfusion CT (which is taken after 2 cycle of the CTx) are compared between CTx-responder and non-responder after finishing 6 cycles of CTx according to RECIST 1.1 criteria.

Perfusion parameters (blood volume, blood flow and permeability) are compared among the different types of the pancreas tumors to investigate perfusion parameters can help characterization of the tumors.

blood volume, blood flow and permeability are compared between the tumor and the pancreas parenchyma.

Seoul National University Hospital

Professor

Carcinoid Tumor

Pancreatic Neuroendocrine Tumor

Central Nervous System Depressants

Anesthetics

All patients in the study will be undergoing both a 68Gallium-DOTATATE scan for tumor localization and planned surgical resection. Both of these maneuvers are clinically indicated and the standard of care in the care of these patients. Following induction of general endotracheal anesthesia (as required for the surgery portion of treatment), the patients will receive an additional injection of 68Gallium-DOTATATE in the operating room itself. A probe that can detect 68Gallium will be used to identify tumors in the OR within the patient's abdominal cavity for targeted resection.

Radioguided Surgery for Pancreatic- Neuroendocrine Cancers

Gallium Dotatate

Sushanth Reddy, MD

The purpose of this study is to see if the use of 68Gallium- positron emission tomography and computer tomography (PET/CT) scans along with NETSPOT® (Advanced Accelerator Applications USA, Inc.) can better define the localization of Neuroendocrine tumors enhancing the surgical removal of Neuroendocrine tumors (NETs).

A challenge during cancer surgery is determining all sites of malignant disease. Accurate tumor localization is of utmost importance as complete resection increases the chance of cure and improves patient outcomes even when cure is not possible. However, finding the primary tumor can be very challenging and, in some cases, impossible. With the recent FDA approval of a PET tracer (Ga-68 DOTATATE) that binds to somatostatin receptors for imaging neuroendocrine tumors (NETs), the investigator's institution has the opportunity to dramatically improve the surgical care for these patients. Therefore, the aim for this study is to develop a molecular image-guided surgery program starting with GI NETs. GI NETs are malignant neoplasms that are increasing in prevalence. NETs cause a variety of debilitating symptoms, and, as a result, contribute substantially to cancer-related morbidity. Since the primary treatment for NET is surgical resection, NETs are an ideal model to launch a comprehensive image-guided surgery program. Many NETs are metastatic at presentation or will develop metastases during their course, and it is difficult to identify all disease visually and through manual palpation. Failure to surgically resect all disease leads to symptoms, metastatic disease, and multiple surgical interventions. Many institutions have recently begun using Ga-68 DOTATATE for PET/CT imaging of NETs, and this same tracer can be used for intra-operative localization of primary NETs as well as metastases. The primary impediment to using Ga-68 DOTATATE for this purpose is the need to develop and validate a high-energy gamma (HEG) probe for detecting NETs during surgery. This study will explore the new PET tracer technology and begin a molecular image-guided surgery program for NETs. This initial paradigm will be used to develop a molecular image guided approach to other cancers. It is expected that this type of program could usher a new era of cancer management at the investigator's institution at its forefront and improve outcomes for study participants.

Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers

Molecular-Guided Surgery for Pancreatic and Gastrointestinal Neuroendocrine Cancers

PET probes will be used to quantify the level of gallium dotatate in the tumor tissue and be compared to the gallium dotatate uptake of the preoperative PET scan.

Using a high energy PET probe the level of gallium uptake will be compared to histopathology analysis of removed specimen

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Role of Perfusion CT in Pancreatic Cancer	NCT01703650	Adenocarcinoma,... Neuroendocrine ...	iopromide CT	18 Years -	Seoul National University Hospital
Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers	NCT03623984	Neuroendocrine ... Carcinoid	Gallium Dotatat...	19 Years - 100 Years	University of Alabama at Birmingham

Spots Global Cancer Trial Database for neuroendocrine carcinoma of pancreas