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Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma

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The Washington University

Status

Completed

Conditions

Adenocarcinoma Pancreas

Treatments

Procedure: PET/MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT02028377
201212004

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Imaging
Experimental group
Description:
PET/MRI
Treatment:
Procedure: PET/MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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