Pancreatic AdenocarcinomaNCT02775786
Prospective Evaluation of MRI Biomarkers in Pancreatic Ductal Adenocarcinoma
A study testing MRIs with and without intravenous contrast (up to 2) in people with Pancreatic Adenocarcinoma, run by Columbia University at 1 site in United States.
Trial summary
This is a prospective cohort study in participants with pancreatic adenocarcinoma who are undergoing surgical resection. Participants will have up to two magnetic resonance imaging (MRI) scans with and without intravenous contrast. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- MRIs with and without intravenous contrast (up to 2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 10 Feb 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years of age.
- Biopsy proved pancreatic ductal adenocarcinoma (PDA) and/or a pancreatic mass with imaging features suggestive of pancreatic adenocarcinoma planned for surgical resection.
- No contraindication to MRI such as severe claustrophobia (not alleviated by oral anti-anxiolytics) or metal/mechanical devices in their body not considered magnetic resonance (MR) compatible at 1.5 Tesla (departmental MRI safety screening form)
- No known allergy to gadolinium based contrast agent
- For contrast enhanced studies, participant has an estimated glomerular filtration rate (GFR) >30 mg/dL using the modification of diet in Renal Disease (MDRD) formula. If the participant has an estimated GFR ≤30 mg/dL, they can still participate but no intravenous contrast will be administered.
Who cannot join
- Contraindication to MR imaging
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Assessing the Utility of Macromolecular Dynamic Contrast Enhanced MRI and Diffusion Weighted Imaging as Biomarkers for Vascular Permeability and Fibrosis in Pancreatic Cancer
This is a prospective cohort study in participants with pancreatic adenocarcinoma who are undergoing surgical resection. Participants will have up to two magnetic resonance imaging (MRI) scans with and without intravenous contrast. The MRI will be performed using either an extracellular contrast agent or using a macromolecular contrast agent. These contrast agents are routinely used in body MRI and are on formulary at this institution. Parameters will be compared to histopathology measures of mean vascular density and grade of fibrosis, respectively. The purpose is to establish a standard protocol for future clinical trials of treatments that would use MRI parameters as quantitative markers of treatment effect.
Read the detailed description
This is a prospective cohort study of dynamic contrast enhanced MRI (DCE-MRI), which includes diffusion weighted imaging (DWI-MRI) in participants with pancreatic adenocarcinoma who are undergoing surgical resection. Participants will have up to two MRI scans with and without intravenous contrast. The MRI will be performed using either an extracellular contrast agent or using a macromolecular contrast agent. These contrast agents are routinely used in body MRI and are on formulary at this institution. Quantitative parameters of volume transfer coefficient (Ktrans) and apparent diffusion coefficient (ADC) will be calculated from the MRI sequences and each parameter will be compared to histopathology measures of mean vascular density and grade of fibrosis, respectively. The influence of the contrast agent (extracellular and macromolecular) on agreement between imaging parameters and histopathology will be assessed and agreement in Ktrans as derived from a one compartment and a two-compartment model will be assessed. If a participant is unable to receive intravenous contrast due to renal dysfunction or refuses IV contrast, the non-contrast portion of the exam will be used for analysis. The purpose is to establish a standard protocol for future clinical trials of treatments that would use MRI parameters as quantitative markers of treatment effect.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- MRIs with and without intravenous contrast (up to 2)
- Keywords
- Pancreatic Adenocarcinoma, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIs with and without intravenous contrast (up to 2)Other
Participants will undergo up to two MRIs with and without intravenous contrast. The first MRI will be performed using an extracellular contrast agent and the second 1-14 days later, with a macromolecular contrast agent. If patient cannot undergo the second MRI for any reason eg. not enough time before surgery, one MRI with either contrast agent will still be used for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | No intervention | Normal volunteers with no pancreas mass or risk factors for pancreas cancer will be recruited for MRI protocol optimization and nothing more. No intravenous contrast will be given. They will be asked to lie in the scanner for up to 1 hour and non-contrast imaging will be performed. |
| Pancreatic Mass or Risk Factors Group | Experimental | Participants with pancreatic adenocarcinoma who are planning to undergo surgical resection. Participants will undergo up to two MRIs with and without intravenous contrast. The first MRI will be performed using an extracellular contrast agent and the second 1-14 days later, with a macromolecular contrast agent. If patient cannot undergo the second MRI for any reason eg. not enough time before surgery, one MRI with either contrast agent will still be used for analysis . Receives: Other: MRIs with and without intravenous contrast (up to 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Apparent Diffusion Coefficient (ADC) of pancreatic cancer based on MRI with percent fibrosis at histopathology
Measured: One year
Secondary outcomes (1)
Correlation between Ktrans of pancreatic cancer derived from dynamic contrast enhanced MRI performed with gadopentetate dimeglumine and mean vascular density quantified at histopathology.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startNov 2013
- Primary completionFeb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lyndon Luk, MD, Principal investigator, CUIMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775786
- Sponsor's protocol ID
- AAAL2505
- Status last verified
- Sep 2024
- First submitted
- 25 Feb 2015
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Utility of Macromolecular Dynamic Contrast Enhanced MRI and Diffusion Weighted Imaging as Biomarkers for Vascular Permeability and Fibrosis in Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02775786
- Acronym / sponsor ID
- AAAL2505
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic Adenocarcinoma, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 18 May 2016 (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 is a prospective cohort study in participants with pancreatic adenocarcinoma who are undergoing surgical resection. Participants will have up to two magnetic resonance imaging (MRI) scans with and without intravenous contrast. The MRI will be performed using either an extracellular contrast agent or using a macromolecular contrast agent. These contrast agents are routinely used in body MRI and are on formulary at this institution. Parameters will be compared to histopathology measures of mean vascular density and grade of fibrosis, respectively. The purpose is to establish a standard protocol for future clinical trials of treatments that would use MRI parameters as quantitative markers of treatment effect.
Detailed description
This is a prospective cohort study of dynamic contrast enhanced MRI (DCE-MRI), which includes diffusion weighted imaging (DWI-MRI) in participants with pancreatic adenocarcinoma who are undergoing surgical resection. Participants will have up to two MRI scans with and without intravenous contrast. The MRI will be performed using either an extracellular contrast agent or using a macromolecular contrast agent. These contrast agents are routinely used in body MRI and are on formulary at this institution. Quantitative parameters of volume transfer coefficient (Ktrans) and apparent diffusion coefficient (ADC) will be calculated from the MRI sequences and each parameter will be compared to histopathology measures of mean vascular density and grade of fibrosis, respectively. The influence of the contrast agent (extracellular and macromolecular) on agreement between imaging parameters and histopathology will be assessed and agreement in Ktrans as derived from a one compartment and a two-compartment model will be assessed. If a participant is unable to receive intravenous contrast due to renal dysfunction or refuses IV contrast, the non-contrast portion of the exam will be used for analysis. The purpose is to establish a standard protocol for future clinical trials of treatments that would use MRI parameters as quantitative markers of treatment effect.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | No intervention | –Normal volunteers with no pancreas mass or risk factors for pancreas cancer will be recruited for MRI protocol optimization and nothing more. No intravenous contrast will be given. They will be asked to lie in the scanner for up to 1 hour and non-contrast imaging will be performed. |
| Pancreatic Mass or Risk Factors Group | Experimental | Other: MRIs with and without intravenous contrast (up to 2)Participants with pancreatic adenocarcinoma who are planning to undergo surgical resection. Participants will undergo up to two MRIs with and without intravenous contrast. The first MRI will be performed using an extracellular contrast agent and the second 1-14 days later, with a macromolecular contrast agent. If patient cannot undergo the second MRI for any reason eg. not enough time before surgery, one MRI with either contrast agent will still be used for analysis . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 18 years of age.
- Biopsy proved pancreatic ductal adenocarcinoma (PDA) and/or a pancreatic mass with imaging features suggestive of pancreatic adenocarcinoma planned for surgical resection.
- No contraindication to MRI such as severe claustrophobia (not alleviated by oral anti-anxiolytics) or metal/mechanical devices in their body not considered magnetic resonance (MR) compatible at 1.5 Tesla (departmental MRI safety screening form)
- No known allergy to gadolinium based contrast agent
- For contrast enhanced studies, participant has an estimated glomerular filtration rate (GFR) >30 mg/dL using the modification of diet in Renal Disease (MDRD) formula. If the participant has an estimated GFR ≤30 mg/dL, they can still participate but no intravenous contrast will be administered.
Key exclusion criteria (2 listed)
- Contraindication to MR imaging
- Pregnancy
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 |
|---|---|---|
| MRIs with and without intravenous contrast (up to 2)Participants will undergo up to two MRIs with and without intravenous contrast. The first MRI will be performed using an extracellular contrast agent and the second 1-14 days later, with a macromolecular contrast agent. If patient cannot undergo the second MRI for any reason eg. not enough time before surgery, one MRI with either contrast agent will still be used for analysis. | Other | Pancreatic Mass or Risk Factors Group |
Primary outcome
Correlation between Apparent Diffusion Coefficient (ADC) of pancreatic cancer based on MRI with percent fibrosis at histopathology
Time frame: One year
1 secondary outcome
Correlation between Ktrans of pancreatic cancer derived from dynamic contrast enhanced MRI performed with gadopentetate dimeglumine and mean vascular density quantified at histopathology.
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Lyndon Luk, MD principal investigator
CUIMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRIs with and without intravenous contrast (up to 2) in people with Pancreatic Adenocarcinoma, run by Columbia University 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Apparent Diffusion Coefficient (ADC) of pancreatic cancer based on MRI with percent fibrosis at histopathology (time frame: One year). 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 19 Sep 2024.