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Status unknownNCT01703650Updated Oct 8, 2020

Role of Perfusion CT in Pancreatic Cancer

An observational study in Adenocarcinoma, Pancreas and Neuroendocrine Carcinoma of Pancreas, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
48
Ages
18 Years and older
Sex
All
01

Study 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).
Read the 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
02

Conditions studied

  • Adenocarcinoma, Pancreas
  • Neuroendocrine Carcinoma of Pancreas

Keywords

  • CT
  • pancreas adenocarcinoma
  • RECIST
  • perfusion
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 48 is below the median of 153 across 332 observational studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
48 participants (actual)

Groups and cohorts

  • Resectable pancreas cancer

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

    Drug: iopromide · Procedure: CT

  • Locally advanced Pancreas cancer

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

    Drug: iopromide · Procedure: CT

Interventions

  • Drugiopromide

    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≤.

    Also known as: Ultravist® (370mgI/mL)

  • ProcedureCT

    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.

06

What researchers measure

Primary outcomes

  1. Evaluation of the correlation between the initial perfusion parameters of the tumor and response of the 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.

    Time frame: after 6 cycles of the planned chemotherapy

Secondary outcomes

  1. Correlation between change of perfusion parameters and the chemotherapy response

    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.

    Time frame: after 6 cycles of the chemotherapy

  2. Perfusion parameters among different pancreas tumors

    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.

    Time frame: within 2 months after finishing enrollment

  3. comparison of perfusion parameters among the pancreas tumors and parenchyma

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

    Time frame: within three weeks before pancreas tumor surgery

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01703650
Lead sponsor
Seoul National University Hospital
Responsible party
Jeong Min Lee (Professor, Seoul National University Hospital) — Principal investigator
First posted
Oct 10, 2012
Start date
Nov 2012
Primary completion
Dec 2015
Completion
Sep 2021 (estimated)
Last update
Oct 8, 2020

Study contacts

Jeong Min Lee, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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