Role of Perfusion CT in Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jeong Min Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01703650
First received: October 6, 2012
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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).

Condition Intervention
Adenocarcinoma, Pancreas
Neuroendocrine Tumor, Pancreas
Drug: iopromide
Procedure: CT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Diagnostic Efficacy of Perfusion CT Using Wide Detector for Staging and Response Prediction After Chemotherapy in Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Correlation between change of perfusion parameters and the chemotherapy response [ Time Frame: after 6 cycles of the chemotherapy ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 2 months after finishing enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: within three weeks before pancreas tumor surgery ] [ Designated as safety issue: No ]
    blood volume, blood flow and permeability are compared between the tumor and the pancreas parenchyma.


Estimated Enrollment: 41
Study Start Date: November 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Resectable pancreas cancer
patients with resectable pancreas adenocarcinoma or neuroendocrine tumor
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 Name: 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
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 Name: 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.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703650

Contacts
Contact: Jeong Min Lee, Professor 82-2-2072-3154 jmsh@snu.ac.kr
Contact: Jeong Hee Yoon, Dr. 82-2-2072-2584 jhjhry@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jeong Min Lee       jmsh@snu.ac.kr   
Principal Investigator: Jeong Min Lee, Professor         
Sub-Investigator: Jeong Hee Yoon, Dr.         
Sub-Investigator: Jin Young Jang, Professor         
Sub-Investigator: Mi Joo Kang, professor         
Sub-Investigator: Yong Tae Kim, professor         
Sub-Investigator: Ji Kon Yu, professor         
Sub-Investigator: Kyung Hoon Lee, professor         
Sub-Investigator: Kyung Bun Lee, professor         
Sub-Investigator: Eun Sun Lee, Dr.         
Sub-Investigator: Se Won Han, professor         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jeong Min Lee, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01703650     History of Changes
Other Study ID Numbers: SNUH_ISS_2012
Study First Received: October 6, 2012
Last Updated: March 19, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
CT
pancreas adenocarcinoma
RECIST

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Neuroendocrine Tumors
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014