2017-06-22
2022-06-01
2022-06-01
70
NCT03012282
University of Washington
University of Washington
INTERVENTIONAL
CT Perfusion Images in Assessing Treatment Response in Patients With Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-01-03 | N/A | 2022-06-30 |
2017-01-05 | N/A | 2022-07-06 |
2017-01-06 | N/A | 2022-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Diagnostic (CT perfusion sequence) 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
|
| Primary Outcome Measures | 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) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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