NCT01703650

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Adenocarcinoma, Pancreas
• Neuroendocrine Carcinoma of Pancreas

Interventions

Type	Name	Description
DRUG	iopromide	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≤.
PROCEDURE	CT	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.

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-12-01
• Completion: 2021-09-01
• First posted: 2012-10-10
• Last updated: 2020-10-08

Locations

1 site across 1 country: South Korea