Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma

Adenocarcinoma Pancreas Clinical Trial

Official title:

Evaluation of the Novel Imaging Modality Simultaneous Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI) in Patients With Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028377
• Other study ID #: 201212004
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: August 22, 2017

Study information

• Verified date: June 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 22, 2017
• Est. primary completion date: August 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma Pancreas

Intervention

Procedure:
• PET/MRI
PET/MRI

Locations

Country	Name	City	State
United States	Washington Unviversity School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Several months or as deemed a surgical candidate by physician.