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.
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.
Study Type
INTERVENTIONAL
Allocation
Undergo DCE MRI
Given IV
OHSU Knight Cancer Institute
Portland, Oregon, United States
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Baseline to up to 2 years
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.
Time frame: Time of enrollment to time of diagnosis, assessed up to 5 years
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.
Time frame: Time of surgical resection to time of disease recurrence, if applicable, assessed up to 5 years
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.
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NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
77
Time frame: Time of surgical resection to time of recurrence, assessed up to 5 years
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.
Time frame: Time of surgical resection to time of death, assessed up to 5 years
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.
Time frame: Time of surgical resection to time of death, assessed up to 5 years
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.
Time frame: Time of surgical resection to time of death, assessed up to 5 years
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.
Time frame: At time of surgery
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.
Time frame: At time of surgery
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.
Time frame: At time of surgery
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.
Time frame: Up to 5 years
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.
Time frame: Once prior to surgery
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.
Time frame: Up to 5 years
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.
Time frame: Once at time of enrollment