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DCE MRI in Patients With Pancreatic Cancer

Primary Purpose

Familial Pancreatic Cancer, Pancreatic Adenocarcinoma, Pancreatic Intraductal Papillary-Mucinous Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Ferumoxytol
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Familial Pancreatic Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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, 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

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

Sites / Locations

  • OHSU Knight Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Arm I (High-risk for familial/hereditary pancreatic cancer)

Arm II (IPMN)

Arm III (Pancreatic cancer)

Arm IV (Healthy volunteers)

Arm Description

Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) yearly for a minimum of 3 scans.

Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) prior to surgery for resection of IPMN.

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.

Patients undergo a single DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) examination.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 21, 2014
Last Updated
August 3, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB), Oregon Health and Science University, National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02070705
Brief Title
DCE MRI in Patients With Pancreatic Cancer
Official Title
The Use of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE MRI) in the Management of Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2014 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB), Oregon Health and Science University, National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK), National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 may have undergone chemotherapy for pancreatic cancer.
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 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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Pancreatic Cancer, Pancreatic Adenocarcinoma, Pancreatic Intraductal Papillary-Mucinous Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (High-risk for familial/hereditary pancreatic cancer)
Arm Type
Experimental
Arm Description
Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) yearly for a minimum of 3 scans.
Arm Title
Arm II (IPMN)
Arm Type
Experimental
Arm Description
Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) prior to surgery for resection of IPMN.
Arm Title
Arm III (Pancreatic cancer)
Arm Type
Experimental
Arm Description
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 Title
Arm IV (Healthy volunteers)
Arm Type
Active Comparator
Arm Description
Patients undergo a single DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) examination.
Intervention Type
Procedure
Intervention Name(s)
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Other Intervention Name(s)
DCE, DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Intervention Description
Undergo DCE MRI
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol
Other Intervention Name(s)
Feraheme, Ferumoxytol Non-Stoichiometric Magnetite
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Presence of pancreatic cancer (yes or no) for patients that are either at high risk for hereditary pancreatic cancer (Group I)
Description
Descriptive statistical analysis will be conducted for primary endpoints.
Time Frame
Up to 5 years
Title
Presence of pancreatic cancer (yes or no) for patients with cystic lesions of the pancreas (Group II)
Description
Descriptive statistical analysis will be conducted for primary endpoints.
Time Frame
Up to 5 years
Title
Change in tumor margins in patients who have undergone chemotherapy for pancreatic cancer (Group III)
Description
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.
Time Frame
Baseline to up to 2 years
Secondary Outcome Measure Information:
Title
Disease free survival (Group I)
Description
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.
Time Frame
Time of enrollment to time of diagnosis, assessed up to 5 years
Title
Disease free survival (Group II)
Description
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.
Time Frame
Time of surgical resection to time of disease recurrence, if applicable, assessed up to 5 years
Title
Disease free survival (Group III)
Description
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.
Time Frame
Time of surgical resection to time of recurrence, assessed up to 5 years
Title
Overall survival (Group I)
Description
Kaplan-Meier method will be used to estimate the survival distribution for overall survival. The estimated median and 95% confidence interval will be computed.
Time Frame
Time of surgical resection to time of death, assessed up to 5 years
Title
Overall survival (Group II)
Description
Kaplan-Meier method will be used to estimate the survival distribution for overall survival. The estimated median and 95% confidence interval will be computed.
Time Frame
Time of surgical resection to time of death, assessed up to 5 years
Title
Overall survival (Group III)
Description
Kaplan-Meier method will be used to estimate the survival distribution for overall survival. The estimated median and 95% confidence interval will be computed.
Time Frame
Time of surgical resection to time of death, assessed up to 5 years
Title
Surgical pathological diagnosis and T & N stage according to the American Joint Committee on Cancer (AJCC) tumor, node, metastasis (TNM) staging system (Group II)
Description
Will be assessed as potential confounders or effect modifiers in the model. Will report c-statistics for each model.
Time Frame
At time of surgery
Title
Surgical pathological diagnosis and T & N stage according to the AJCC TNM staging system (Group III)
Description
Will be assessed as potential confounders or effect modifiers in the model. Will report c-statistics for each model.
Time Frame
At time of surgery
Title
Resection margin status (R0, R1 or R2) (Group III)
Description
Will be assessed as potential confounders or effect modifiers in the model. Will report c-statistics for each model.
Time Frame
At time of surgery
Title
DCE- MRI imaging parameters (Group I)
Description
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.
Time Frame
Up to 5 years
Title
DCE- MRI imaging parameters (Group II)
Description
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.
Time Frame
Once prior to surgery
Title
DCE- MRI imaging parameters (Group III)
Description
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.
Time Frame
Up to 5 years
Title
DCE- MRI imaging parameters and descriptional analysis of normal pancreas DCE- MRI images (Group IV)
Description
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.
Time Frame
Once at time of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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, 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 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. (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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Guimaraes
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander S. Guimaraes
Phone
503-494-4254
First Name & Middle Initial & Last Name & Degree
Alexander S. Guimaraes

12. IPD Sharing Statement

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DCE MRI in Patients With Pancreatic Cancer

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