Clinical trial NCT02028377: Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma
Official title: Evaluation of the Novel Imaging Modality Simultaneous Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI) in Patients With Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenocarcinoma Pancreas
Keywords: Adenocarcinoma
imaging
PET
MRI
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will use PET/MRI in patients with adenocarcinoma of the pancreas to identify hidden metastatic disease or identify patients with borderline or locally advanced disease.

Detailed description: Patients will receive a PET/MRI scan within 6 weeks of their standard of care imaging. There is no maximum number of scans for research. The number of scans depends on each patient's treatment plan.

Eligibility criteria: Inclusion Criteria:

* Presence of suspicious lesion of the pancreas consistent with pancreatic adenocarcinoma. Cytological confirmation is not required.
* Patients preparing to receive therapy for pancreas cancer, including patients enrolled in NCT01413022
* Patient must be 18 years or older
* Patient must have a life expectancy of more than 6 months and performance status of 2 or less
* Patient must be able to understand and willing to sign an approved written informed consent document
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the length of the study
* Patients enrolled in the Clinical trials.gov# NCT01413022 trial must meet both studies eligibility criteria.

Exclusion Criteria:

* Patient must not have had prior resection for pancreatic adenocarcinoma.
* Patient must not have a history of other malignancy less than or equal to 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix
* Patient must not be unable to receive a PET-MRI scan due to renal function, allergy or other problem with receiving or tolerating an MRI scan, etc. All patients will fill out a standard MRI screening form.
* Patients must not have a blood glucose of greater than or equal to 200mg/dL at the time of PET-MRI or if a patient is diabetic and glucose is not controlled. At the discretion of the PI and the authorized user and with their approval prior to 2-\[18\]fluoro-2-deoxy-D-glucose (FDG) injection, patients with blood glucose ≥ 200 mg/dL may participate in the study.
* Patient must not be pregnant and/or breast feeding

Primary outcomes:
measure: PET/MRI compared to conventional CT and MRI
timeFrame: Up to several months or longer. Patient will undergo research imaging with each standard of care scan they have.
Secondary outcomes:
measure: Resectability post neoadjuvant treatment
timeFrame: Several months or as deemed a surgical candidate by physician.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington Unviversity School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ryan C. Fields, MD
role: PRINCIPAL_INVESTIGATOR
References: