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

Not Applicable

Terminated

• Conditions: Pancreatic Ductal Adenocarcinoma
• Interventions: Diagnostic Test: Computed Tomography Perfusion Imaging

• Registration Number: NCT03012282
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Study Start: 2017-06-22
• Status Verified: 2022-06
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (CT perfusion sequence)	Computed Tomography Perfusion Imaging	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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 of pre-treatment CT tumor perfusion parameters with overall survival	At 2 years	Assessed using Cox regression models. Multivariate Cox models will be constructed if multiple parameters are found to be predictive of survival.
Correlation of pre-treatment CT tumor perfusion parameters with progression free survival	At 2 years	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 (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.
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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States