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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01780 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9625 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| RG3017007 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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Termination due to slow accrual
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (CT perfusion sequence) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography Perfusion Imaging | Diagnostic Test | Undergo CT perfusion sequence |
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| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan O'Malley | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| 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) |