Familial Pancreatic CancerNCT02070705
DCE MRI in Patients With Pancreatic Cancer
A study testing Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Ferumoxytol in people with Familial Pancreatic Cancer and Pancreatic Adenocarcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a procedure that takes detailed pictures of functional and structural properties inside the body using magnetic field imaging. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Familial Pancreatic Cancer, Pancreatic Adenocarcinoma, Pancreatic Intraductal Papillary-Mucinous Neoplasm
- What is being tested?
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Ferumoxytol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2014to 7 Aug 2024
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ALL PARTICIPANTS: A negative serum or urine pregnancy test for woman of childbearing potential
- ALL PARTICIPANTS: Ability to understand and the willingness to sign a written informed consent document
- GROUPS 1, 2, AND 3: "All participants" described above
- GROUPS 1, 2, AND 3: Must be consented for the Oregon Pancreatic Tumor Registry (OPTR)
- GROUPS 1, 2, AND 3: Group 1: participants identified as being high-risk for familial or hereditary pancreatic cancer, and must conform to one or more of the following requirements:
- Have a strong family history of pancreatic cancer; this is defined as pancreatic cancer occurring in one first- degree relative and two other relatives, or two first- degree relatives; or,
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- Have a known high-risk genetic syndrome (e.g., BRCA 1\&2, STK11, CDNK2A, PRSS1, and MSH 2\&6)
- GROUPS 1, 2, AND 3: Group 2 participants identified as having IPMN on standard radiographic imaging that meets criteria for resection based on symptoms or on conventional imaging (computed tomography [CT] or MRI) findings
- GROUPS 1, 2, AND 3: Group 3 participants must have pathologically- confirmed pancreatic adenocarcinoma, with or without the need for neoadjuvant chemotherapy prior to surgical resection.
- HEALTHY VOLUNTEERS (Group 4): Must meet inclusion criteria for "all participants" described above
- HEALTHY VOLUNTEERS (Group 4): Group 4 participants must have no history of cancer, pancreatic disease, or family history of pancreatic cancer.
- Family history will be defined as pancreatic cancer occurring in one first-degree relative and two other relatives, or two first-degree relatives
Who cannot join
- Participants unable or unwilling to give written, informed consent or to undergo MRI imaging
- Participants with multiple drug allergies, and/or subjects who have had an allergic reaction to any intravenous iron replacement product, or a known history of hypersensitivity to ferumoxytol
- Participants with concurrent clinical diagnosis, evidence of suspected hemochromatosis, or other diseases of iron metabolism (i.e., iron overload)
- Cirrhosis, cardiomyopathy, restrictive heart disease, or bronzing of the skin
- Pregnant women are excluded from this study because there is an unknown, but potential risk, for adverse events, as small animal trials have linked ferumoxytol administration (at very high doses) to birth defects (e.g., soft-tissue malformations and decreased fetal weights); it is not known whether ferumoxytol is present in human milk; breastfeeding, however, should be discontinued if the mother receives ferumoxytol while nursing
- Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol
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- Participants with diagnosis of renal insufficiency or glomerular filtration rate (GFR) < 60 ml/min/1.73m^2
- Adult patients who require monitored anesthesia for MRI scanning
- Participants with any contraindications to gadolinium-based contrast agents
- Participants who have a contraindication for MRI (e.g. metal in their bodies, a cardiac pacemaker, or other incompatible device), or are severely agitated or claustrophobic. (For patients that are eligible but there is a concern of metal in their bodies, the will be given the option if interested to have a x-ray completed prior to study enrollment to determine if they can proceed with the study MRI. Patients with a concern of metal in their bodies that don't agree to a x-ray will not be enrolled into the study.)
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: The Use of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE MRI) in the Management of Pancreatic Cancer
This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a procedure that takes detailed pictures of functional and structural properties inside the body using magnetic field imaging. These images may better characterize pancreatic cancer in patients at high risk or in patients who may have undergone chemotherapy for pancreatic cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the ability of DCE-MRI to identify the presence of pancreatic cancer in patients at high risk for hereditary pancreatic cancer.
II. Assess the ability of DCE-MRI to identify the presence of pancreatic cancer in patients with cystic lesions of the pancreas.
III. Assess the ability of DCE-MRI to accurately predict tumor margins in patients who have undergone chemotherapy for pancreatic cancer.
IV. Obtain DCE-MRI scans of from healthy volunteers (Group 4), to establish baseline imaging parameters of the normal, non-diseased pancreas for use as a comparator to affected pancreata.
SECONDARY OBJECTIVE:
- Clinical factors associated with the presence of pancreatic cancer will be assessed in each of the three experimental groups, including disease free survival and overall survival.
II. Additional MRI pulses sequences (e.g. MR fingerprinting, etc.) will be acquired for the assessment of tissue contrast before and after the administration of contrast agents.
OUTLINE: Patients are assigned to 1 of 4 groups.
ARM I (High-risk for familial or hereditary pancreatic cancer): Patients undergo DCE MRI yearly for a minimum of 3 scans.
ARM II (Intraductal papillary mucinous neoplasms [IPMN]): Patients undergo DCE MRI prior to surgery for resection of IPMN.
ARM III (Pancreatic cancer): Patients who undergo chemotherapy prior to resection will have 2 DCE MRI scans; one study scan prior to undergoing neoadjuvant therapy, as well as one study scan following neoadjuvant therapy as part of their pre-operative work up in addition to the standard imaging studies. For patients that do not require chemotherapy treatment prior to resection they will have just one DCE MRI scan prior to surgical resection. Patients currently undergoing neoadjuvant therapy or who have already completed neoadjuvant therapy that were unable to undergo imaging at baseline and are now proceeding to resection will have one DCE MRI scan prior to surgical resection.
ARM IV (Healthy volunteers): Patients undergo a single DCE MRI examination.
- Conditions
- Familial Pancreatic Cancer, Pancreatic Adenocarcinoma, Pancreatic Intraductal Papillary-Mucinous Neoplasm
- Being tested
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Ferumoxytol
- Medical subject headings
- Pancreatic carcinoma, familial, Pancreatic Intraductal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called DCE, DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Undergo DCE MRI
FerumoxytolDrug
Also called Feraheme, Ferumoxytol Non-Stoichiometric Magnetite
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (High-risk for familial/hereditary pancreatic cancer) | Experimental | Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) yearly for a minimum of 3 scans. Receives: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol |
| Arm II (IPMN) | Experimental | Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) prior to surgery for resection of IPMN. Receives: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol |
| Arm III (Pancreatic cancer) | Experimental | Patients who undergo chemotherapy prior to resection will have 2 DCE MRI scans; one study scan prior to undergoing neoadjuvant therapy, as well as one study scan following neoadjuvant therapy as part of their pre-operative work up in addition to the standard imaging studies. For patients that do not require chemotherapy treatment prior to resection they will have just one DCE MRI scan prior to surgical resection. Patients currently undergoing neoadjuvant therapy or who have already completed neoadjuvant therapy that were unable to undergo imaging at baseline and are now proceeding to resection will have one DCE MRI scan prior to surgical resection. Receives: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol |
| Arm IV (Healthy volunteers) | Active comparator | Patients undergo a single DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) examination. Receives: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pancreatic cancer (yes or no) for patients that are either at high risk for hereditary pancreatic cancer (Group I)
Descriptive statistical analysis will be conducted for primary endpoints.
Measured: Up to 5 years
Presence of pancreatic cancer (yes or no) for patients with cystic lesions of the pancreas (Group II)
Descriptive statistical analysis will be conducted for primary endpoints.
Measured: Up to 5 years
Change in tumor margins in patients who have undergone chemotherapy for pancreatic cancer (Group III)
The change of dynamic contrast enhanced magnetic resonance imaging (DCE MRI) parameters from baseline will be correlated with the tumor margins determined by pathological specimen following surgical resection through linear regression model.
Measured: Baseline to up to 2 years
Secondary outcomes (13)
Disease free survival (Group I)
Kaplan-Meier method will be used to estimate the survival distribution for disease free survival. The estimated median and 95% confidence interval will be computed.
Measured: Time of enrollment to time of diagnosis, assessed up to 5 years
Disease free survival (Group II)
Kaplan-Meier method will be used to estimate the survival distribution for disease free survival. The estimated median and 95% confidence interval will be computed.
Measured: Time of surgical resection to time of disease recurrence, if applicable, assessed up to 5 years
Disease free survival (Group III)
Kaplan-Meier method will be used to estimate the survival distribution for disease free survival. The estimated median and 95% confidence interval will be computed.
Measured: Time of surgical resection to time of recurrence, assessed up to 5 years
Overall survival (Group I)
Kaplan-Meier method will be used to estimate the survival distribution for overall survival. The estimated median and 95% confidence interval will be computed.
Measured: Time of surgical resection to time of death, assessed up to 5 years
Overall survival (Group II)
Kaplan-Meier method will be used to estimate the survival distribution for overall survival. The estimated median and 95% confidence interval will be computed.
Measured: Time of surgical resection to time of death, assessed up to 5 years
Overall survival (Group III)
Kaplan-Meier method will be used to estimate the survival distribution for overall survival. The estimated median and 95% confidence interval will be computed.
Measured: Time of surgical resection to time of death, assessed up to 5 years
Surgical pathological diagnosis and T & N stage according to the American Joint Committee on Cancer (AJCC) tumor, node, metastasis (TNM) staging system (Group II)
Will be assessed as potential confounders or effect modifiers in the model. Will report c-statistics for each model.
Measured: At time of surgery
Surgical pathological diagnosis and T & N stage according to the AJCC TNM staging system (Group III)
Will be assessed as potential confounders or effect modifiers in the model. Will report c-statistics for each model.
Measured: At time of surgery
Resection margin status (R0, R1 or R2) (Group III)
Will be assessed as potential confounders or effect modifiers in the model. Will report c-statistics for each model.
Measured: At time of surgery
DCE- MRI imaging parameters (Group I)
The DCE- MRI parameters will be obtained from the pancreases in the control group and will be descriptively analyzed for use as a comparison in other groups.
Measured: Up to 5 years
DCE- MRI imaging parameters (Group II)
The DCE- MRI parameters will be obtained from the pancreases in the control group and will be descriptively analyzed for use as a comparison in other groups.
Measured: Once prior to surgery
DCE- MRI imaging parameters (Group III)
The DCE- MRI parameters will be obtained from the pancreases in the control group and will be descriptively analyzed for use as a comparison in other groups.
Measured: Up to 5 years
DCE- MRI imaging parameters and descriptional analysis of normal pancreas DCE- MRI images (Group IV)
The DCE- MRI parameters will be obtained from the pancreases in the control group and will be descriptively analyzed for use as a comparison in other groups.
Measured: Once at time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study start31 Jan 2014
- Primary completion7 Aug 2024
- Study completion7 Aug 2024
Why it stopped: Loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), Oregon Health and Science University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alexander Guimaraes, OHSU Knight Cancer Institute
- Investigators
- Alexander Guimaraes, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070705
- Sponsor's protocol ID
- IRB00009694
- Other IDs
- NCI-2014-00270, MR00045736, CR00022704, IRB00009694, K08EB012859, U01CA278923
- Status last verified
- Jul 2025
- First submitted
- 21 Feb 2014
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE MRI) in the Management of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02070705
- Acronym / sponsor ID
- IRB00009694
- Conditions
- Familial Pancreatic Cancer, Pancreatic Adenocarcinoma, Pancreatic Intraductal Papillary-Mucinous Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 77 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), Oregon Health and Science University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Cancer Institute (NCI)
- Study start
- 31 Jan 2014 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 25 Feb 2014 (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 clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a procedure that takes detailed pictures of functional and structural properties inside the body using magnetic field imaging. These images may better characterize pancreatic cancer in patients at high risk or in patients who may have undergone chemotherapy for pancreatic cancer.
Detailed description
PRIMARY OBJECTIVES:
- Assess the ability of DCE-MRI to identify the presence of pancreatic cancer in patients at high risk for hereditary pancreatic cancer.
II. Assess the ability of DCE-MRI to identify the presence of pancreatic cancer in patients with cystic lesions of the pancreas.
III. Assess the ability of DCE-MRI to accurately predict tumor margins in patients who have undergone chemotherapy for pancreatic cancer.
IV. Obtain DCE-MRI scans of from healthy volunteers (Group 4), to establish baseline imaging parameters of the normal, non-diseased pancreas for use as a comparator to affected pancreata.
SECONDARY OBJECTIVE:
- Clinical factors associated with the presence of pancreatic cancer will be assessed in each of the three experimental groups, including disease free survival and overall survival.
II. Additional MRI pulses sequences (e.g. MR fingerprinting, etc.) will be acquired for the assessment of tissue contrast before and after the administration of contrast agents.
OUTLINE: Patients are assigned to 1 of 4 groups.
ARM I (High-risk for familial or hereditary pancreatic cancer): Patients undergo DCE MRI yearly for a minimum of 3 scans.
ARM II (Intraductal papillary mucinous neoplasms [IPMN]): Patients undergo DCE MRI prior to surgery for resection of IPMN.
ARM III (Pancreatic cancer): Patients who undergo chemotherapy prior to resection will have 2 DCE MRI scans; one study scan prior to undergoing neoadjuvant therapy, as well as one study scan following neoadjuvant therapy as part of their pre-operative work up in addition to the standard imaging studies. For patients that do not require chemotherapy treatment prior to resection they will have just one DCE MRI scan prior to surgical resection. Patients currently undergoing neoadjuvant therapy or who have already completed neoadjuvant therapy that were unable to undergo imaging at baseline and are now proceeding to resection will have one DCE MRI scan prior to surgical resection.
ARM IV (Healthy volunteers): Patients undergo a single DCE MRI examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (High-risk for familial/hereditary pancreatic cancer) | Experimental | Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Drug: FerumoxytolPatients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) yearly for a minimum of 3 scans. |
| Arm II (IPMN) | Experimental | Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Drug: FerumoxytolPatients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) prior to surgery for resection of IPMN. |
| Arm III (Pancreatic cancer) | Experimental | Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Drug: FerumoxytolPatients who undergo chemotherapy prior to resection will have 2 DCE MRI scans; one study scan prior to undergoing neoadjuvant therapy, as well as one study scan following neoadjuvant therapy as part of their pre-operative work up in addition to the standard imaging studies. For patients that do not require chemotherapy treatment prior to resection they will have just one DCE MRI scan prior to surgical resection. Patients currently undergoing neoadjuvant therapy or who have already completed neoadjuvant therapy that were unable to undergo imaging at baseline and are now proceeding to resection will have one DCE MRI scan prior to surgical resection. |
| Arm IV (Healthy volunteers) | Active comparator | Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Drug: FerumoxytolPatients undergo a single DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) examination. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ALL PARTICIPANTS: A negative serum or urine pregnancy test for woman of childbearing potential
- ALL PARTICIPANTS: Ability to understand and the willingness to sign a written informed consent document
- GROUPS 1, 2, AND 3: "All participants" described above
- GROUPS 1, 2, AND 3: Must be consented for the Oregon Pancreatic Tumor Registry (OPTR)
- GROUPS 1, 2, AND 3: Group 1: participants identified as being high-risk for familial or hereditary pancreatic cancer, and must conform to one or more of the following requirements:
Key exclusion criteria (10 listed)
- Participants unable or unwilling to give written, informed consent or to undergo MRI imaging
- Participants with multiple drug allergies, and/or subjects who have had an allergic reaction to any intravenous iron replacement product, or a known history of hypersensitivity to ferumoxytol
- Participants with concurrent clinical diagnosis, evidence of suspected hemochromatosis, or other diseases of iron metabolism (i.e., iron overload)
- Cirrhosis, cardiomyopathy, restrictive heart disease, or bronzing of the skin
- Pregnant women are excluded from this study because there is an unknown, but potential risk, for adverse events, as small animal trials have linked ferumoxytol administration (at very high doses) to birth defects (e.g., soft-tissue malformations and decreased fetal weights); it is not known whether ferumoxytol is present in human milk; breastfeeding, however, should be discontinued if the mother receives ferumoxytol while nursing
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 |
|---|---|---|
| Dynamic Contrast-Enhanced Magnetic Resonance ImagingAlso: DCE, DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRIUndergo DCE MRI | Procedure or surgery | Arm I (High-risk for familial/hereditary pancreatic cancer), Arm II (IPMN), Arm III (Pancreatic cancer), Arm IV (Healthy volunteers) |
| FerumoxytolAlso: Feraheme, Ferumoxytol Non-Stoichiometric MagnetiteGiven IV | Drug | Arm I (High-risk for familial/hereditary pancreatic cancer), Arm II (IPMN), Arm III (Pancreatic cancer), Arm IV (Healthy volunteers) |
Primary outcome
Presence of pancreatic cancer (yes or no) for patients that are either at high risk for hereditary pancreatic cancer (Group I)
Time frame: Up to 5 years
Descriptive statistical analysis will be conducted for primary endpoints.
Presence of pancreatic cancer (yes or no) for patients with cystic lesions of the pancreas (Group II)
Time frame: Up to 5 years
Descriptive statistical analysis will be conducted for primary endpoints.
Change in tumor margins in patients who have undergone chemotherapy for pancreatic cancer (Group III)
Time frame: Baseline to up to 2 years
The change of dynamic contrast enhanced magnetic resonance imaging (DCE MRI) parameters from baseline will be correlated with the tumor margins determined by pathological specimen following surgical resection through linear regression model.
13 secondary outcomes
Disease free survival (Group I)
Time frame: Time of enrollment to time of diagnosis, assessed up to 5 years
Disease free survival (Group II)
Time frame: Time of surgical resection to time of disease recurrence, if applicable, assessed up to 5 years
Disease free survival (Group III)
Time frame: Time of surgical resection to time of recurrence, assessed up to 5 years
Overall survival (Group I)
Time frame: Time of surgical resection to time of death, assessed up to 5 years
Overall survival (Group II)
Time frame: Time of surgical resection to time of death, assessed up to 5 years
Overall survival (Group III)
Time frame: Time of surgical resection to time of death, assessed up to 5 years
Surgical pathological diagnosis and T & N stage according to the American Joint Committee on Cancer (AJCC) tumor, node, metastasis (TNM) staging system (Group II)
Time frame: At time of surgery
Surgical pathological diagnosis and T & N stage according to the AJCC TNM staging system (Group III)
Time frame: At time of surgery
Resection margin status (R0, R1 or R2) (Group III)
Time frame: At time of surgery
DCE- MRI imaging parameters (Group I)
Time frame: Up to 5 years
DCE- MRI imaging parameters (Group II)
Time frame: Once prior to surgery
DCE- MRI imaging parameters (Group III)
Time frame: Up to 5 years
DCE- MRI imaging parameters and descriptional analysis of normal pancreas DCE- MRI images (Group IV)
Time frame: Once at time of enrollment
Results and safety
The study was stopped early (reason given: Loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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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.
Alexander Guimaraes principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Ferumoxytol in people with Familial Pancreatic Cancer and Pancreatic Adenocarcinoma, run by OHSU Knight Cancer Institute 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 12 inclusion and 10 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 31 Jul 2025. 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: Loss of funding). 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?
Presence of pancreatic cancer (yes or no) for patients that are either at high risk for hereditary pancreatic cancer (Group I) (time frame: Up to 5 years). The study lists 3 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 31 Jul 2025.