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

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03012282
• Other study ID #: 9625
• Secondary ID: NCI-2016-0178096
• Status: Terminated
• Phase: N/A
• Start date: June 22, 2017
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Ductal Adenocarcinoma

Intervention

Diagnostic Test:
• Computed Tomography Perfusion Imaging
Undergo CT perfusion sequence

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)