Role of Perfusion CT in Pancreatic Cancer

NCT ID: NCT01703650

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2021-09-30

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

Conditions

Adenocarcinoma, Pancreas; Neuroendocrine Carcinoma of Pancreas

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Resectable pancreas cancer

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

iopromide

Intervention Type: DRUG

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≤.

CT

Intervention Type: PROCEDURE

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.

Locally advanced Pancreas cancer

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

iopromide

Intervention Type: DRUG

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≤.

CT

Intervention Type: PROCEDURE

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.

Interventions

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≤.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Other Intervention Names

Ultravist® (370mgI/mL)

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeong Min Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeong Min Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SNUH_ISS_2012

Identifier Type: -

Identifier Source: org_study_id