Pancreatic Ductal Adenocarcinoma
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTComputed Tomography Perfusion Imaging
Undergo CT perfusion sequence
Sponsors
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of pre-treatment CT tumor perfusion parameters with overall survival | At 1 year | Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival. |
| Correlation between pre-treatment computed tomography (CT) tumor perfusion parameters and percentage of patients who achieve curative (R0) surgical resection after neoadjuvant chemotherapy | Up to 4 years | 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. |
| Correlation between pre-treatment CT tumor perfusion parameters and tumor response after treatment | Up to 1 year | 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. |
| Correlation of pre-treatment CT tumor perfusion parameters with progression free survival | At 1 year | Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival. |
| Change in computed tomography (CT) tumor perfusion parameters (time to peak concentration) | Baseline to post-treatment (up to approximately one year) | 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. |
| Change in CT tumor perfusion parameter (blood flow) | Baseline to post-treatment (up to approximately one year) | 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. |
| Change in CT tumor perfusion parameter (blood volume) | Baseline to post-treatment (up to approximately one year) | 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. |
| Change in CT tumor perfusion parameter (Ktrans) | Baseline to post-treatment (up to approximately one year) | 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. |
Countries
United States
Outcome results
None listed