Clinical trial NCT01703650: Role of Perfusion CT in Pancreatic Cancer
Official title: Evaluation of Diagnostic Efficacy of Perfusion CT Using Wide Detector for Staging and Response Prediction After Chemotherapy in Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenocarcinoma, Pancreas
Neuroendocrine Carcinoma of Pancreas
Keywords: CT
pancreas adenocarcinoma
RECIST
perfusion
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Primary outcomes:
measure: Evaluation of the correlation between the initial perfusion parameters of the tumor and response of the chemotherapy
timeFrame: after 6 cycles of the planned chemotherapy
Secondary outcomes:
measure: Correlation between change of perfusion parameters and the chemotherapy response
timeFrame: after 6 cycles of the chemotherapy
measure: Perfusion parameters among different pancreas tumors
timeFrame: within 2 months after finishing enrollment
measure: comparison of perfusion parameters among the pancreas tumors and parenchyma
timeFrame: within three weeks before pancreas tumor surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: