PDAC - Pancreatic Ductal AdenocarcinomaNCT05669287
Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics
A study testing CT Perfusion in people with PDAC - Pancreatic Ductal Adenocarcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
With CT-perfusion(CTP) it is possible to visualize the enhancement pattern of the tumor. The perfusion CT, interleaved with a routine contrast enhanced CT (CECT) will be performed at diagnosis in all patients (goal: n=125 patients) and at the first follow-up at 3 months in patients treated with systemic therapy (goal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PDAC - Pancreatic Ductal Adenocarcinoma
- What is being tested?
- CT Perfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Dec 2017to 1 Jun 2023
- 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
- Clinical suspicion of pancreatic cancer
- 18 years and older
- written (signed and dated) informed consent
Who cannot join
- Contra-indications to undergo CT (due to untreatable contrast allergy or renal function impairment)
- Previous treatment for pancreatic cancer
- Concomitant malignancies. Subjects with prior malignancies must be disease-free for at least 5 years
- Insufficient command of the Dutch language to be able to understand the patient information
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Hospital
Nijmegen, Gelderland, 6525GA
John Hermans, john.hermans@radboudumc.nl
About this study
With CT-perfusion(CTP) it is possible to visualize the enhancement pattern of the tumor. The perfusion CT, interleaved with a routine contrast enhanced CT (CECT) will be performed at diagnosis in all patients (goal: n=125 patients) and at the first follow-up at 3 months in patients treated with systemic therapy (goal: n=50 patients). Also, the histopathology will be collected for resected tumors to perform histopathology analysis. CTP parameters will be correlated to immunohistological findings and clinical outcome.
The main goal of the study is to create an AI-assisted method to classify patients with a vascular phenotype of pancreatic ductal adenocarcinoma (PDAC). The investigators expect that this phenotype can be used to predict overall survival and chemotherapy response.
- Conditions
- PDAC - Pancreatic Ductal Adenocarcinoma
- Being tested
- CT Perfusion
- Keywords
- Pancreas, Pancreatic cancer, CT perfusion, Histopathology, Imaging Biomarker
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT PerfusionDiagnostic test
CT Perfusion
| Study group | Role | What they receive |
|---|---|---|
| CT Perfusion | Experimental | All patients will receive a baseline CT Perfusion scan. A subgroup of patients with chemotherapy treatment will receive a follow-up CT Perfusion after 3 months. Receives: Diagnostic Test: CT Perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of vascular phenotype using CT-perfusion
To classify a vascular phenotype with CTP using automated perfusion analysis in patients with pancreatic ductal adenocarcinoma
Measured: Baseline
Correlation of CT-perfusion features with histopathological features
To correlate the vascular phenotype with histopathologic features (stroma and microvessel density) in patients with pancreatic ductal adenocarcinoma
Measured: Baseline, Time of Resection
Secondary outcomes (3)
Association between survival and CT-perfusion features
Automated AI analysis of survival using CT perfusion in patients with pancreatic ductal adenocarcinoma.
Measured: Baseline, at 2 Years
Prediction of chemotherapy response
Sensitivity and specificity of CT-perfusion parameters to predict chemotherapy response in patients with pancreatic ductal adenocarcinoma.
Measured: Baseline, 3 Months
Prediction of chemotherapy response compared to RECIST
Sensitivity and specificity of CT-perfusion parameters to evaluate chemotherapy response in patients with pancreatic ductal adenocarcinoma, compared to RECIST 1.1 on conventional CECT.
Measured: Baseline, 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start22 Dec 2017
- Primary completion31 Dec 2022
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDAC - Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
- Investigators
- John Hermans, MSc, MD, PhD, Principal investigator, Radboud University Medical CenterHenkjan Huisman, MSc, PhD, Principal investigator, Radboud University Medical CenterLodewijk Brosens, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669287
- Sponsor's protocol ID
- PERFUSION-PANC
- Other IDs
- 12034
- Status last verified
- Dec 2022
- First submitted
- 20 Dec 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining a Vascular Phenotype of Pancreatic Ductal Adenocarcinoma With CT Perfusion Using Quantitative Radiomics
- ClinicalTrials.gov ID
- NCT05669287
- Acronym / sponsor ID
- PERFUSION-PANC
- Conditions
- PDAC - Pancreatic Ductal Adenocarcinoma
- Keywords
- Pancreas, Pancreatic cancer, CT perfusion, Histopathology, Imaging Biomarker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 30 Dec 2022 (actual)
- 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.
With CT-perfusion(CTP) it is possible to visualize the enhancement pattern of the tumor. The perfusion CT, interleaved with a routine contrast enhanced CT (CECT) will be performed at diagnosis in all patients (goal: n=125 patients) and at the first follow-up at 3 months in patients treated with systemic therapy (goal: n=50 patients). Also, the histopathology will be collected for resected tumors to perform histopathology analysis. CTP parameters will be correlated to immunohistological findings and clinical outcome.
The main goal of the study is to create an AI-assisted method to classify patients with a vascular phenotype of pancreatic ductal adenocarcinoma (PDAC). The investigators expect that this phenotype can be used to predict overall survival and chemotherapy response.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT Perfusion | Experimental | Diagnostic Test: CT PerfusionAll patients will receive a baseline CT Perfusion scan. A subgroup of patients with chemotherapy treatment will receive a follow-up CT Perfusion after 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical suspicion of pancreatic cancer
- 18 years and older
- written (signed and dated) informed consent
Key exclusion criteria (4 listed)
- Contra-indications to undergo CT (due to untreatable contrast allergy or renal function impairment)
- Previous treatment for pancreatic cancer
- Concomitant malignancies. Subjects with prior malignancies must be disease-free for at least 5 years
- Insufficient command of the Dutch language to be able to understand the patient information
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 |
|---|---|---|
| CT PerfusionCT Perfusion | Diagnostic test | CT Perfusion |
Primary outcome
Classification of vascular phenotype using CT-perfusion
Time frame: Baseline
To classify a vascular phenotype with CTP using automated perfusion analysis in patients with pancreatic ductal adenocarcinoma
Correlation of CT-perfusion features with histopathological features
Time frame: Baseline, Time of Resection
To correlate the vascular phenotype with histopathologic features (stroma and microvessel density) in patients with pancreatic ductal adenocarcinoma
3 secondary outcomes
Association between survival and CT-perfusion features
Time frame: Baseline, at 2 Years
Prediction of chemotherapy response
Time frame: Baseline, 3 Months
Prediction of chemotherapy response compared to RECIST
Time frame: Baseline, 3 Months, 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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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.
John Hermans, MSc, MD, PhD principal investigator
Radboud University Medical Center
Henkjan Huisman, MSc, PhD principal investigator
Radboud University Medical Center
Lodewijk Brosens principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Perfusion in people with PDAC - Pancreatic Ductal Adenocarcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 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: status not confirmed, as of the sponsor's last update on 3 May 2023. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Perik, Msc. (024 3617899, tom.perik@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of vascular phenotype using CT-perfusion (time frame: Baseline). The study lists 2 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 3 May 2023.