A Study Using Magnetic Resonance Imaging (MRI) as a Non-invasive Method for Assessing Pancreatic Fibrosis (MINIMAP)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-008810
Sponsor Protocol Number: DK 108328-S1
About this study
The purpose of this study is to evaluate magnetic resonance imaging (MRI) as a non-invasive imaging method to detect chronic pancreatitis (CP) and quantify pancreatic fibrosis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Enrollment in Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (The PROCEED Study).
- Participant will be undergoing an MRI of the pancreas for clinical indications OR will be undergoing an MRI of the pancreas for research as part of their participation in the PROCEED Study.
- All participants must sign an informed consent indicating that they are aware of the investigational nature of this study and are willing to undergo MRI evaluation, and authorizing the use of their protected health information for research purposes.
Exclusion Criteria:
- Age < 18 or >75 years old.
- Weight ≥ 350 lbs.
- Evidence of dense calcific CP, as detected on any abdominal imaging study (the presence of < 10 punctuate calcifications measuring < 3mm is not an exclusion), verified by a CPDPC site radiologist.
- Presence of >3 cm peri-pancreatic fluid collection.
- Prior documented allergy to secretin.
- History of moderate or severe allergic reaction to gadolinium-based contrast agent.
- Pregnancy.
- Documented history of inflammatory bowel disease or vagotomy.
- Active, acute pancreatitis flare.
- Claustrophobia and/or need for general anesthesia to undergo MRI.
- History of acute kidney injury within the preceding 6 weeks, with no confirmation that serum creatinine has returned to normal.
- Known estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2.
- Severe COPD limiting breath-holding for MRI.
- Moderate or large volume ascites (of any etiology).
- Known hemochromatosis.
- Known cystic fibrosis homozygosity.
- History of splenectomy.
- Patients with therapeutic body implants; specifically, pacemakers, defibrillators, or other implanted electronic devices that are not MRI-compatible will be excluded. Patients with an IVC filter, body piercing, neurosurgical clip placement, or shrapnel injury will be evaluated on an individual basis.
- Unwilling or unable to give written, informed consent.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Santhi Swaroop Vege, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available