Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma

NCT02028377 | Completed DMC

• 1 other identifier: 201212004
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma Pancreas

Keywords

Adenocarcinoma; imaging; PET; MRI

Outcome Measures

Primary Outcomes (1)

• PET/MRI compared to conventional CT and MRI

  Primary outcome is to determine if the primary tumor and the margins of anatomical land marks from the PET/MRI imaging is more precise and gives a clearer picture of tumor location than standard care, CT or MRI. Both standard of care imaging and this new technology will be compared to the final pathologic analysis, measuring the true distance (in mm) between the primary tumor and margins. Data will be reported as mm.

  Up to several months or longer. Patient will undergo research imaging with each standard of care scan they have.

Secondary Outcomes (1)

• Resectability post neoadjuvant treatment

  Several months or as deemed a surgical candidate by physician.

Study Arms (1)

Imaging

EXPERIMENTAL

PET/MRI

Procedure: PET/MRI

Interventions

PET/MRI PROCEDURE

PET/MRI

Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington Unviversity School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Adenocarcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ryan C. Fields, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: January 7, 2014
• Study Start: February 1, 2013
• Primary Completion: August 22, 2017
• Study Completion: August 22, 2017
• Last Updated: June 25, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)