DCE MRI in Diagnosing Patients With Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by OHSU Knight Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT02070705
First received: February 21, 2014
Last updated: July 24, 2015
Last verified: July 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Presence of pancreatic cancer (yes or no) for patients with cystic lesions of the pancreas (Group II) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Erin Gilbert OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT02070705     History of Changes
Other Study ID Numbers: 9694, NCI-2014-00270, MR00045736, CR00022704, 9694, P30CA069533
Study First Received: February 21, 2014
Last Updated: July 24, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 30, 2015