Clinical Trial: DCE MRI in Diagnosing Patients With Pancreatic Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Use of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE MRI) in the Management of Pancreatic Cancer

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 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.

Detailed Summary:

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.

Sponsor: OHSU Knight Cancer Institute

Current Primary Outcome:

• 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 ]

Original Primary Outcome:

• The presence of pancreatic cancer (Arms I & II) [ Time Frame: Up to 4 years ]
  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 ]
  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.

Current Secondary Outcome:

• 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 ]

Original Secondary Outcome:

• 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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  Assessed as potential confounders or effect modifiers in the model.

Information By: OHSU Knight Cancer Institute

Dates:
Date Received: February 21, 2014
Date Started: January 2014
Date Completion: December 2018
Last Updated: April 28, 2017
Last Verified: April 2017