CT Perfusion Images in Assessing Treatment Response in Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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This pilot clinical trial studies how well computed tomography (CT) perfusion images work in assessing treatment response in patients with pancreatic cancer. Analyzing specific measurements on the CT perfusion images may help doctors better determine how a tumor responds to chemotherapy and/or radiation therapy and may help guide treatment for patients with pancreatic cancer.

Detailed Description
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OUTLINE: Patients undergo CT perfusion sequence during the first 40 seconds of the baseline standard of care CT scan and during follow-up CT scans at 2 and possibly 4 months after chemotherapy, at 4-6 weeks after radiation therapy, or prior to definitive surgery. After completion of the study, patients are followed up periodically for 2 years.

Official Title
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Evaluation of CT Perfusion Parameters as a Potential Biomarker for Treatment Response in Pancreatic Cancer

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Diagnostic Test: Computed Tomography Perfusion Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent form A diagnosis of pancreatic ductal adenocarcinoma Exclusion Criteria: Patients unable to provide informed consent Women who are pregnant or intending to become pregnant during the study Patients with body mass index greater than 40 kg/m^2 History of severe allergic-like reaction to iodinated contrast media

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (CT perfusion sequence)<br>Patients undergo CT perfusion sequence during the first 40 seconds of the baseline standard of care CT scan and during follow-up CT scans at 2 and possibly 4 months after chemotherapy, at 4-6 weeks after radiation therapy, or prior to definitive surgery. | Diagnostic Test: Computed Tomography Perfusion Imaging<br>* Undergo CT perfusion sequence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between pre-treatment computed tomography (CT) tumor perfusion parameters and percentage of patients who achieve curative (R0) surgical resection after neoadjuvant chemotherapy | Assessed using logistic regression. Receiver operating characteristic (ROC) curve analysis will be used to examine the sensitivity and specificity of different thresholds for each parameter. | Up to 4 years | 
| Correlation between pre-treatment CT tumor perfusion parameters and tumor response after treatment | Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Assessed using logistic regression. ROC curve analysis will be used to examine the sensitivity and specificity of different thresholds for each parameter. If multiple perfusion parameters are found to be predictive of response, a multivariate logistic regression model will be constructed with these variables. ROC analysis will also be used to summary the predictive performance of the multivariate model. | Up to 1 year | 
| Correlation of pre-treatment CT tumor perfusion parameters with overall survival | Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival. | At 1 year | 
| Correlation of pre-treatment CT tumor perfusion parameters with overall survival | Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival. | At 2 years | 
| Correlation of pre-treatment CT tumor perfusion parameters with progression free survival | Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival. | At 1 year | 
| Correlation of pre-treatment CT tumor perfusion parameters with progression free survival | Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival. | At 2 years | 
| Change in computed tomography (CT) tumor perfusion parameters (time to peak concentration) | The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test. | Baseline to post-treatment (up to approximately one year) | 
| Change in CT tumor perfusion parameter (blood flow) | The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test. | Baseline to post-treatment (up to approximately one year) | 
| Change in CT tumor perfusion parameter (blood volume) | The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test. | Baseline to post-treatment (up to approximately one year) | 
| Change in CT tumor perfusion parameter (Ktrans) | The change in each CT tumor perfusion parameter between the pre-treatment scan and the post-treatment scan where response is assessed will be calculated. These changes will be compared between the responders and non-responders using the t-test or Mann-Whitney test. | Baseline to post-treatment (up to approximately one year) |