Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma

NCT ID: NCT02028377

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-08-22

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.

Conditions

Adenocarcinoma Pancreas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Imaging

PET/MRI

Group Type: EXPERIMENTAL

PET/MRI

Intervention Type: PROCEDURE

PET/MRI

Interventions

PET/MRI

PET/MRI

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan C. Fields, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington Unviversity School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201212004

Identifier Type: -

Identifier Source: org_study_id