DCE MRI in Diagnosing Patients With Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 24, 2014
Last verified: February 2014
  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 Cancer
Intraductal Papillary Mucinous Neoplasm of the Pancreas
Recurrent Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Device: 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:
  • The presence of pancreatic cancer (Arms I & II) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Descriptive statistical analysis will be conducted for primary endpoints. Kappa statistic, overall percent of agreement, positive percent agreement and negative percent agreement will be computed for assessing agreement between DCE MRI approach and the standard imaging approach.

  • Change in tumor margins (Arm 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.


Secondary Outcome Measures:
  • Disease free survival (DFS) (Arm 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 in each patient group. The estimated median and 95% confidence interval will be computed.

  • DFS (Arm II & 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 in each patient group. The estimated median and 95% confidence interval will be computed.

  • Overall survival (Arms I, II, & 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 in each patient group. The estimated median and 95% confidence interval will be computed.

  • Surgical pathological diagnosis (Arm II & III) [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
    Surgical pathological diagnosis, pathological stage and resection margin status will be assessed as potential confounders or effect modifiers in the model. C-statistics will be reported for each model.

  • T and N stage according to the American Joint Committee on Cancer TNM staging system (Arm II & III) [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
    Surgical pathological diagnosis, pathological stage and resection margin status will be assessed as potential confounders or effect modifiers in the model. C-statistics will be reported for each model.

  • Resection margin status (R0, R1 or R2) (Arm III) [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
    Assessed as potential confounders or effect modifiers in the model.


Estimated Enrollment: 150
Study Start Date: January 2014
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (High-risk for familial or hereditary pancreatic cancer)
Patients undergo DCE MRI for up to 3 scans.
Device: dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE MRI
Other Name: DCE-MRI
Experimental: Arm II (IPMN)
Patients undergo DCE MRI prior to surgery.
Device: dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE MRI
Other Name: DCE-MRI
Experimental: Arm III (Unresectable pancreatic cancer)
Patients undergo DCE MRI before and after neoadjuvant therapy.
Device: dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE MRI
Other Name: DCE-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 treatment arms.

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
  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, 9694, P30CA069533
Study First Received: February 21, 2014
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014