Pancreatic Ductal AdenocarcinomaNCT03012282
CT Perfusion Images in Assessing Treatment Response in Patients With Pancreatic Cancer
A study testing Computed Tomography Perfusion Imaging in people with Pancreatic Ductal Adenocarcinoma, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Computed Tomography Perfusion Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2017to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- A diagnosis of pancreatic ductal adenocarcinoma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Computed Tomography Perfusion Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography Perfusion ImagingDiagnostic test
Undergo CT perfusion sequence
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Computed Tomography Perfusion Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to post-treatment (up to approximately one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start22 Jun 2017
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Why it stopped: Termination due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan O'Malley, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012282
- Sponsor's protocol ID
- 9625
- Other IDs
- NCI-2016-01780, 9625, RG3017007
- Status last verified
- Jun 2022
- First submitted
- 3 Jan 2017
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of CT Perfusion Parameters as a Potential Biomarker for Treatment Response in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03012282
- Acronym / sponsor ID
- 9625
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination due to slow accrual
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CT perfusion sequence) | Experimental | Diagnostic Test: Computed Tomography Perfusion ImagingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent form
- A diagnosis of pancreatic ductal adenocarcinoma
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed Tomography Perfusion ImagingUndergo CT perfusion sequence | Diagnostic test | Diagnostic (CT perfusion sequence) |
Primary outcome
Correlation between pre-treatment computed tomography (CT) tumor perfusion parameters and percentage of patients who achieve curative (R0) surgical resection after neoadjuvant chemotherapy
Time frame: 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 between pre-treatment CT tumor perfusion parameters and tumor response after treatment
Time frame: 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.
Correlation of pre-treatment CT tumor perfusion parameters with overall survival
Time frame: At 1 year
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 overall survival
Time frame: 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
Time frame: At 1 year
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
Time frame: 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)
Time frame: 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)
Time frame: 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 volume)
Time frame: 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)
Time frame: 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.
Results and safety
The study was stopped early (reason given: Termination due to slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan O'Malley principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography Perfusion Imaging in people with Pancreatic Ductal Adenocarcinoma, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Termination due to slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between pre-treatment computed tomography (CT) tumor perfusion parameters and percentage of patients who achieve curative (R0) surgical resection after neoadjuvant chemotherapy (time frame: Up to 4 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.