We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02028377
Previous Study | Return to List | Next Study

Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02028377
First Posted: January 7, 2014
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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.

Condition Intervention
Adenocarcinoma Pancreas Procedure: PET/MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Novel Imaging Modality Simultaneous Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI) in Patients With Pancreatic Adenocarcinoma

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • PET/MRI compared to conventional CT and MRI [ Time Frame: Up to several months or longer. Patient will undergo research imaging with each standard of care scan they have. ]
    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 [ Time Frame: Several months or as deemed a surgical candidate by physician. ]
    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.


Estimated Enrollment: 100
Actual Study Start Date: February 2013
Estimated Study Completion Date: January 2021
Primary Completion Date: August 22, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imaging
PET/MRI
Procedure: PET/MRI
PET/MRI

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028377


Locations
United States, Missouri
Washington Unviversity School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Ryan C. Fields, MD Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02028377     History of Changes
Other Study ID Numbers: 201212004
First Submitted: September 23, 2013
First Posted: January 7, 2014
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per, XII.1 and 2, Name and contact information will be kept for future research.

Keywords provided by Washington University School of Medicine:
Adenocarcinoma
imaging
PET
MRI

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms