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DCE MRI in Diagnosing Patients With Pancreatic Cancer

This study is currently recruiting participants.
Verified April 2017 by Erin Gilbert, OHSU Knight Cancer Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02070705
First Posted: February 25, 2014
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Erin Gilbert, OHSU Knight Cancer Institute
  Purpose
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 and radio frequency pulses. These pictures may help identify underlying malignancy in patients at high risk or active malignancy in patients who have undergone chemotherapy for pancreatic cancer.

Condition Intervention
Hereditary Pancreatic Carcinoma Pancreatic Adenocarcinoma Pancreatic Intraductal Papillary-Mucinous Neoplasm Unresectable Pancreatic Cancer Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Use of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE MRI) in the Management of Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Erin Gilbert, OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Change in tumor margins in patients who have undergone chemotherapy for pancreatic cancer (Group III) [ Time Frame: Baseline to up to 4 years ]
    The change of DCE MRI parameters from baseline will be correlated with the tumor margins determined by pathological specimen following surgical resection through linear regression model.

  • 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 4 years ]
  • Presence of pancreatic cancer (yes or no) for patients with cystic lesions of the pancreas (Group II) [ Time Frame: Up to 4 years ]

Secondary Outcome Measures:
  • Disease free survival (Group I) [ Time Frame: Time of enrollment to time of most recent standard surveillance imaging to occur every 6-12 months, assessed up to 4 years ]
    Kaplan-Meier method will be used to estimate the survival distribution for disease free survival.

  • Disease free survival (Group II) [ Time Frame: Time of surgical resection to time of most recent standard surveillance imaging to occur every 3-6 months, assessed up to 4 years ]
    Kaplan-Meier method will be used to estimate the survival distribution for disease free survival.

  • Disease free survival (Group III) [ Time Frame: Time of surgical resection to time of most recent standard surveillance imaging to occur every 3-6 months, assessed up to 4 years ]
    Kaplan-Meier method will be used to estimate the survival distribution for disease free survival.

  • Overall survival (Group I) [ Time Frame: Time of surgical resection to time of most recent follow up, assessed up to 4 years ]
    Kaplan-Meier method will be used to estimate the survival distribution for overall survival.

  • Overall survival (Group II) [ Time Frame: Time of surgical resection to time of most recent follow up, assessed up to 4 years ]
    Kaplan-Meier method will be used to estimate the survival distribution for overall survival.

  • Overall survival (Group III) [ Time Frame: Time of surgical resection to time of most recent follow up, assessed up to 4 years ]
    Kaplan-Meier method will be used to estimate the survival distribution for overall survival.

  • Resection margin status (R0, R1 or R2) (Group III) [ Time Frame: At time of surgery ]
  • 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 ]
  • Surgical pathological diagnosis and T & N stage according to the American Joint Committee on Cancer (AJCC) primary tumor, regional nodes, metastasis (TNM) staging system (Group III) [ Time Frame: At time of surgery ]

Estimated Enrollment: 150
Study Start Date: January 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (High-risk for familial/hereditary pancreatic cancer)
Patients undergo DCE MRI for up to 3 scans.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
Other Names:
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI
Experimental: Arm II (IPMN)
Patients undergo DCE MRI prior to surgery.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
Other Names:
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI
Experimental: Arm III (Unresectable pancreatic cancer)
Patients undergo DCE MRI before and after neoadjuvant therapy.
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
Other Names:
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI

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 to DCE MRI to accurately predict tumor margins in patients who have undergone chemotherapy for pancreatic cancer.

SECONDARY OBJECTIVES:

I. In each of the three groups listed above clinical factors associated with the presence of pancreatic cancer will be analyzed; in addition, disease free survival and overall survival will be analyzed in each group.

OUTLINE: Patients are assigned to 1 of 3 groups.

ARM I (High-risk for familial or hereditary pancreatic cancer): Patients undergo DCE MRI for up to 3 scans.

ARM II (Intraductal Papillary Mucinous Neoplasms (IPMN)): Patients undergo DCE MRI prior to surgery.

ARM III (Unresectable pancreatic cancer): Patients undergo DCE MRI before and after neoadjuvant therapy.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be consented for the Oregon Pancreatic Tumor Registry (OPTR)
  • Must not have contraindication for MRI or intravenous (IV) contrast administration

Exclusion Criteria:

  • Allergy to intravenous contrast agents Prohance or Ferumoxytol
  Contacts and Locations
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
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)
Investigators
Principal Investigator: Erin Gilbert OHSU Knight Cancer Institute
  More Information

Responsible Party: Erin Gilbert, Assistant Professor, 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
CR00022704
9694 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Submitted: February 21, 2014
First Posted: February 25, 2014
Last Update Posted: May 2, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Pancreatic Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases