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

NCT03012282 | Terminated DMC

• 3 other identifiers: 9625NCI-2016-01780RG3017007
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (10)

• 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)

Study Arms (1)

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.

Diagnostic Test: Computed Tomography Perfusion Imaging

Interventions

Computed Tomography Perfusion Imaging DIAGNOSTIC_TEST

Undergo CT perfusion sequence

Diagnostic (CT perfusion sequence)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form
• A diagnosis of pancreatic ductal adenocarcinoma

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Study Officials

• Ryan O'Malley

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 6, 2017
• Study Start: June 22, 2017
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)