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DCE MRI in Patients With Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02070705
Recruitment Status : Recruiting
First Posted : February 25, 2014
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Erin Gilbert, OHSU Knight Cancer Institute

Brief 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. These images may better characterize pancreatic cancer in patients at high risk or in patients who have undergone chemotherapy for pancreatic cancer.

Condition or disease Intervention/treatment Phase
Healthy Subject Hereditary Pancreatic Carcinoma Pancreatic Adenocarcinoma Pancreatic Intraductal Papillary Mucinous Neoplasm Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Drug: Ferumoxytol Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. 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 characterize tumor margins in patients who have undergone chemotherapy or chemoradiotherapy for pancreatic cancer.

IV. Establish baseline DCE-MR imaging parameters of the normal, non-diseased pancreas for use as a comparator to affected pancreata.

SECONDARY OBJECTIVES:

I. 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 will be calculated for each experimental group.

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 undergo DCE MRI before and after receiving neoadjuvant therapy for borderline or locally advanced pancreatic cancer.

ARM IV (Healthy volunteers): Patients undergo a single DCE MRI examination.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Use of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE MRI) in the Management of Pancreatic Cancer
Actual Study Start Date : January 31, 2014
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: Arm I (High-risk for familial/hereditary pancreatic cancer)
Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) yearly for a minimum of 3 scans.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
Other Names:
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI

Drug: Ferumoxytol
Given IV
Other Names:
  • Feraheme
  • Ferumoxytol Non-Stoichiometric Magnetite

Experimental: Arm II (IPMN)
Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) prior to surgery for resection of IPMN.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
Other Names:
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI

Drug: Ferumoxytol
Given IV
Other Names:
  • Feraheme
  • Ferumoxytol Non-Stoichiometric Magnetite

Experimental: Arm III (Pancreatic cancer)
Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) before and after receiving neoadjuvant therapy for borderline or locally advanced pancreatic cancer.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
Other Names:
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI

Drug: Ferumoxytol
Given IV
Other Names:
  • Feraheme
  • Ferumoxytol Non-Stoichiometric Magnetite

Active Comparator: Arm IV (Healthy volunteers)
Patients undergo a single DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) examination.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
Other Names:
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI

Drug: Ferumoxytol
Given IV
Other Names:
  • Feraheme
  • Ferumoxytol Non-Stoichiometric Magnetite




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Disease free survival (Group I) [ Time Frame: Time of enrollment to time of diagnosis, assessed up to 5 years ]
    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.

  2. Disease free survival (Group II) [ Time Frame: Time of surgical resection to time of disease recurrence, if applicable, assessed up to 5 years ]
    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.

  3. Disease free survival (Group III) [ Time Frame: Time of surgical resection to time of recurrence, assessed up to 5 years ]
    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.

  4. Overall survival (Group I) [ Time Frame: Time of surgical resection to time of death, assessed up to 5 years ]
    Kaplan-Meier method will be used to estimate the survival distribution for overall survival. The estimated median and 95% confidence interval will be computed.

  5. Overall survival (Group II) [ Time Frame: Time of surgical resection to time of death, assessed up to 5 years ]
    Kaplan-Meier method will be used to estimate the survival distribution for overall survival. The estimated median and 95% confidence interval will be computed.

  6. Overall survival (Group III) [ Time Frame: Time of surgical resection to time of death, assessed up to 5 years ]
    Kaplan-Meier method will be used to estimate the survival distribution for overall survival. The estimated median and 95% confidence interval will be computed.

  7. Surgical pathological diagnosis and T & N stage according to the American Joint Committee on Cancer (AJCC) TNM staging system (Group II) [ Time Frame: At time of surgery ]
    Will be assessed as potential confounders or effect modifiers in the model. Will report c-statistics for each model.

  8. Surgical pathological diagnosis and T & N stage according to the AJCC TNM staging system (Group III) [ Time Frame: At time of surgery ]
    Will be assessed as potential confounders or effect modifiers in the model. Will report c-statistics for each model.

  9. Resection margin status (R0, R1 or R2) (Group III) [ Time Frame: At time of surgery ]
    Will be assessed as potential confounders or effect modifiers in the model. Will report c-statistics for each model.

  10. DCE- MRI imaging parameters (Group I) [ Time Frame: Up to 5 years ]
    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.

  11. DCE- MRI imaging parameters (Group II) [ Time Frame: Once prior to surgery ]
    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.

  12. DCE- MRI imaging parameters (Group III) [ Time Frame: Up to 5 years ]
    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.

  13. DCE- MRI imaging parameters and descriptional analysis of normal pancreas DCE- MRI images (Group IV) [ Time Frame: Once at time of enrollment ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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,
    • Have a known high-risk genetic syndrome (e.g., BRCA 1&2, STK11, CDNK2A, PRSS1, MSH 2&6, etc...)
  • GROUPS 1, 2, AND 3: Group 2 participants identified as having IPMN on standard radiographic (computed tomography [CT] or magnetic resonance imaging [MRI]) imaging that meets criteria for resection based on symptoms or on imaging findings
  • GROUPS 1, 2, AND 3: Group 3 participants must have pathologically- confirmed pancreatic adenocarcinoma and have been determined to have 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070705


Locations
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United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Erin Gilbert    503-494-6900    gilberte@ohsu.edu   
Principal Investigator: Erin Gilbert         
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Principal Investigator: Erin Gilbert OHSU Knight Cancer Institute

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Responsible Party: Erin Gilbert, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT02070705     History of Changes
Other Study ID Numbers: IRB00009694
NCI-2014-00270 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MR00045736 ( Other Identifier: OHSU Knight Cancer Institute )
CR00022704 ( Other Identifier: OHSU Knight Cancer Institute )
IRB00009694 ( Other Identifier: OHSU Knight Cancer Institute )
K08EB012859 ( U.S. NIH Grant/Contract )
P30CA069533 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatic Intraductal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions