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

Evaluation of CT Perfusion Parameters as a Potential Biomarker for Treatment Response in 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.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Diagnostic test: Computed Tomography Perfusion Imaging

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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; Undergo CT perfusion sequence

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Ryan O'Malley, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 9625 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2016-01780 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); RG3017007 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No