Role of Perfusion CT in Pancreatic Cancer

October 6, 2020 updated by: Jeong Min Lee, Seoul National University Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Resectable pancreas tumor group patients with resectable pancreas adenocarcinoma or neuroendocrine tumor

Locally advanced pancreas tumor group Patients with locally advanced pancreas cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Resectable pancreas cancer
patients with resectable pancreas adenocarcinoma or neuroendocrine tumor underwent perfusion CT after intravenous iopromide administration
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≤.
Other Names:
  • Ultravist® (370mgI/mL)
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.
Locally advanced Pancreas cancer
Patients with locally advanced pancreas cancer underwent perfusion CT after intravenous iopromide administration before and after chemotherapy.
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≤.
Other Names:
  • Ultravist® (370mgI/mL)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the correlation between the initial perfusion parameters of the tumor and response of the chemotherapy
Time Frame: 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.
after 6 cycles of the planned chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between change of perfusion parameters and the chemotherapy response
Time Frame: 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.
after 6 cycles of the chemotherapy
Perfusion parameters among different pancreas tumors
Time Frame: 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.
within 2 months after finishing enrollment
comparison of perfusion parameters among the pancreas tumors and parenchyma
Time Frame: within three weeks before pancreas tumor surgery
blood volume, blood flow and permeability are compared between the tumor and the pancreas parenchyma.
within three weeks before pancreas tumor surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

October 6, 2012

First Submitted That Met QC Criteria

October 6, 2012

First Posted (Estimate)

October 10, 2012

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH_ISS_2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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