Role of Perfusion CT in Pancreatic Cancer
- Conditions
- Adenocarcinoma, PancreasNeuroendocrine Carcinoma of Pancreas
- Interventions
- Procedure: CT
- Registration Number
- NCT01703650
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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).
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
- patients who are older than eighteen years
- patients in whom operation and preoperative computed tomography are scheduled for resectable pancreas adenocarcinoma or pancreas neuroendocrine tumor
- patients in whom chemotherapy is scheduled for histologically confirmed pancreas adenocarcinoma
- patients in whom chemotherapy is planned for highly suspicious pancreas adenocarcinoma on imaging workup
- patients who agree with the study and whose informed consent is obtained.
- patients who are younger than eighteen years old
- patients in whom previously radiation therapy was performed and the RTx field includes pancreas
- patients with recurred pancreas adenocarcinoma
- patient who are pregnant or nursing patients
- patients with renal failure (GFR<30mL/min)
- patients with history of malignancy, except malignancy is in complete remission after operation or iodine therapy for at least five years)
- patients with hypersensitivity for iodine or contrast media or other causes of contraindication of contrast-media enhanced CT scan
- Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completion of the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Resectable pancreas cancer CT patients with resectable pancreas adenocarcinoma or neuroendocrine tumor underwent perfusion CT after intravenous iopromide administration Locally advanced Pancreas cancer CT Patients with locally advanced pancreas cancer underwent perfusion CT after intravenous iopromide administration before and after chemotherapy. Resectable pancreas cancer iopromide patients with resectable pancreas adenocarcinoma or neuroendocrine tumor underwent perfusion CT after intravenous iopromide administration Locally advanced Pancreas cancer iopromide Patients with locally advanced pancreas cancer underwent perfusion CT after intravenous iopromide administration before and after chemotherapy.
- Primary Outcome Measures
Name Time Method Evaluation of the correlation between the initial perfusion parameters of the tumor and response of the chemotherapy after 6 cycles of the planned chemotherapy 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.
- Secondary Outcome Measures
Name Time Method Correlation between change of perfusion parameters and the chemotherapy response after 6 cycles of the chemotherapy 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 among different pancreas tumors within 2 months after finishing enrollment 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.
comparison of perfusion parameters among the pancreas tumors and parenchyma within three weeks before pancreas tumor surgery blood volume, blood flow and permeability are compared between the tumor and the pancreas parenchyma.
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of