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Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma

Primary Purpose

Adenocarcinoma Pancreas

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/MRI
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenocarcinoma Pancreas focused on measuring Adenocarcinoma, imaging, PET, MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington Unviversity School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging

Arm Description

PET/MRI

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Resectability post neoadjuvant treatment
The secondary outcome is to determine if PET/MRI imaging is better than standard of care imaging (CT or MRI) after patients have received chemotherapy and to determine if they are surgical candidates. The objective 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.

Full Information

First Posted
September 23, 2013
Last Updated
June 20, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02028377
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
August 22, 2017 (Actual)
Study Completion Date
August 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma Pancreas
Keywords
Adenocarcinoma, imaging, PET, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imaging
Arm Type
Experimental
Arm Description
PET/MRI
Intervention Type
Procedure
Intervention Name(s)
PET/MRI
Intervention Description
PET/MRI
Primary Outcome Measure Information:
Title
PET/MRI compared to conventional CT and MRI
Description
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.
Time Frame
Up to several months or longer. Patient will undergo research imaging with each standard of care scan they have.
Secondary Outcome Measure Information:
Title
Resectability post neoadjuvant treatment
Description
The secondary outcome is to determine if PET/MRI imaging is better than standard of care imaging (CT or MRI) after patients have received chemotherapy and to determine if they are surgical candidates. The objective 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.
Time Frame
Several months or as deemed a surgical candidate by physician.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan C. Fields, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Unviversity School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Per, XII.1 and 2, Name and contact information will be kept for future research.

Learn more about this trial

Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma

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