Role of Perfusion CT in Pancreatic Cancer

NCT01703650 | Unknown DMC

• 1 other identifier: SNUH_ISS_2012
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is

1. 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. 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).

Conditions

Adenocarcinoma, Pancreas; Neuroendocrine Carcinoma of Pancreas

Keywords

CT; pancreas adenocarcinoma; RECIST; perfusion

Outcome Measures

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.

  after 6 cycles of the planned chemotherapy

Secondary Outcomes (3)

• Correlation between change of perfusion parameters and the chemotherapy response

  after 6 cycles of the chemotherapy

• Perfusion parameters among different pancreas tumors

  within 2 months after finishing enrollment

• comparison of perfusion parameters among the pancreas tumors and parenchyma

  within three weeks before pancreas tumor surgery

Study Arms (2)

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

iopromide 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≤.

Also known as: Ultravist® (370mgI/mL)

Locally advanced Pancreas cancer; Resectable pancreas cancer

CT 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; Resectable pancreas cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Adenocarcinoma

Interventions

iopromide

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Jeong Min Lee, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 6, 2012
• First Posted: October 10, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)