2014-01-31
2024-08-07
2024-08-07
77
NCT02070705
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
INTERVENTIONAL
DCE MRI in Patients With Pancreatic Cancer
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2014-02-21 | N/A | 2025-01-02 |
2014-02-24 | N/A | 2025-01-03 |
2014-02-25 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Arm I (High-risk for familial/hereditary pancreatic cancer) Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) yearly for a minimum of 3 scans. | PROCEDURE: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
DRUG: Ferumoxytol
|
EXPERIMENTAL: Arm II (IPMN) Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) prior to surgery for resection of IPMN. | PROCEDURE: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
DRUG: Ferumoxytol
|
EXPERIMENTAL: 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 stand | PROCEDURE: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
DRUG: Ferumoxytol
|
ACTIVE_COMPARATOR: Arm IV (Healthy volunteers) Patients undergo a single DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) examination. | PROCEDURE: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
DRUG: Ferumoxytol
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
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. | 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. | 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. | Baseline to up to 2 years |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
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 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 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. | 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 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 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 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. | 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. | 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. | 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. | 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. | 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. | 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. | Once at time of enrollment |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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