Clinical trial NCT03012282: CT Perfusion Images in Assessing Treatment Response in Patients With Pancreatic Cancer
Official title: Evaluation of CT Perfusion Parameters as a Potential Biomarker for Treatment Response in Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between pre-treatment computed tomography (CT) tumor perfusion parameters and percentage of patients who achieve curative (R0) surgical resection after neoadjuvant chemotherapy
timeFrame: Up to 4 years
measure: Correlation between pre-treatment CT tumor perfusion parameters and tumor response after treatment
timeFrame: Up to 1 year
measure: Correlation of pre-treatment CT tumor perfusion parameters with overall survival
timeFrame: At 1 year
measure: Correlation of pre-treatment CT tumor perfusion parameters with overall survival
timeFrame: At 2 years
measure: Correlation of pre-treatment CT tumor perfusion parameters with progression free survival
timeFrame: At 1 year
measure: Correlation of pre-treatment CT tumor perfusion parameters with progression free survival
timeFrame: At 2 years
measure: Change in computed tomography (CT) tumor perfusion parameters (time to peak concentration)
timeFrame: Baseline to post-treatment (up to approximately one year)
measure: Change in CT tumor perfusion parameter (blood flow)
timeFrame: Baseline to post-treatment (up to approximately one year)
measure: Change in CT tumor perfusion parameter (blood volume)
timeFrame: Baseline to post-treatment (up to approximately one year)
measure: Change in CT tumor perfusion parameter (Ktrans)
timeFrame: Baseline to post-treatment (up to approximately one year)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Ryan O'Malley
role: PRINCIPAL_INVESTIGATOR
References: