MR Guidance for Liver and Pancreas

April 5, 2023 updated by: University Health Network, Toronto

A Feasibility Study of Magnetic Resonance Imaging (MRI) as a Platform for Image Guidance and Adaptive Radiation Therapy in Patients With Liver or Pancreatic Cancer

This is a single centre, single arm, prospective feasibility study that aims to see whether magnetic resonance imaging (MRI) as a source of image guidance before each radiation treatment fraction is feasible, and also if it may provide information that could potentially be used during the treatment to improve the radiation treatment plan.

Patients will have 5 MRIs with each of their RT sessions. If patients' RT treatment will consist of more than 5 fractions, only 5 MRIs will be done with any 5 RT fractions. Patients will be completing a short questionnaire at the end of each MRI. A patient questionnaire will also be completed at the end of the study to assess for patient satisfaction.

There will be 30 evaluable patients enrolled to the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network - Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with locally advanced pancreatic cancer or hepatocellular carcinoma being considered for treatment with chemoradiation, long course RT, or SBRT with curative intent or palliative intent, planned for 5 or more RT fractions

Description

Inclusion Criteria:

  • Patients 18 years or older
  • Diagnosed with locally advanced pancreatic cancer or hepatocellular carcinoma being considered for treatment with chemoradiation, long course RT, or SBRT with curative intent or palliative intent, planned for 5 or more RT fractions

Exclusion Criteria:

- Contraindications for MRI: ferromagnetic prosthesis, pacemaker / implanted defibrillator, claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pancreatic Cancer
Approximately 10 patients with pancreatic cancer will be enrolled to the study with the primary aim of determining the feasibility of using off-line MRI-guidance during the course of radiation treatment
Other: MRI
Patients who consent to this study will have an abdominal MRI prior to or immediately after each fraction of radiation treatment in the case of those patients that are undergoing SBRT or those receiving palliative treatment. On patients receiving definitive chemoradiation, an abdominal MRI will be performed prior to or immediately after radiation treatment once per week during the any five weeks of treatment
Liver Metastases
Approximately 10 patients with liver mets will be enrolled to the study with the primary aim of determining the feasibility of using off-line MRI-guidance during the course of radiation treatment
Other: MRI
Patients who consent to this study will have an abdominal MRI prior to or immediately after each fraction of radiation treatment in the case of those patients that are undergoing SBRT or those receiving palliative treatment. On patients receiving definitive chemoradiation, an abdominal MRI will be performed prior to or immediately after radiation treatment once per week during the any five weeks of treatment
Hepatocellular carcinoma
Approximately 10 patients with HCC will be enrolled to the study with the primary aim of determining the feasibility of using off-line MRI-guidance during the course of radiation treatment
Other: MRI
Patients who consent to this study will have an abdominal MRI prior to or immediately after each fraction of radiation treatment in the case of those patients that are undergoing SBRT or those receiving palliative treatment. On patients receiving definitive chemoradiation, an abdominal MRI will be performed prior to or immediately after radiation treatment once per week during the any five weeks of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Survey
Time Frame: At study completion (day5 or week 5, depending on type of treatment)
To evaluate patient satisfaction with the MR guidance process, a modified version of a questionnaire previously used at our institution will be performed at the end of the study
At study completion (day5 or week 5, depending on type of treatment)
MRI-Anxiety Questionnaire
Time Frame: Prior to or before MR session 1 (day 1 or week 1, depending on type of treatment)
This instrument will be used to evaluate patient related anxiety after each MR
Prior to or before MR session 1 (day 1 or week 1, depending on type of treatment)
MRI-Anxiety Questionnaire
Time Frame: Prior to or before MR session 2 (day 2 or week 2, depending on type of treatment)
This instrument will be used to evaluate patient related anxiety after each MR
Prior to or before MR session 2 (day 2 or week 2, depending on type of treatment)
MRI-Anxiety Questionnaire
Time Frame: Prior to or before MR session 3 (day 3 or week 3, depending on type of treatment)
This instrument will be used to evaluate patient related anxiety after each MR
Prior to or before MR session 3 (day 3 or week 3, depending on type of treatment)
MRI-Anxiety Questionnaire
Time Frame: Prior to or before MR session 4 (day 4 or week 4, depending on type of treatment)
This instrument will be used to evaluate patient related anxiety after each MR
Prior to or before MR session 4 (day 4 or week 4, depending on type of treatment)
MRI-Anxiety Questionnaire
Time Frame: Prior to or before MR session 5 (day 5 or week 5, depending on type of treatment)
his instrument will be used to evaluate patient related anxiety after each MR
Prior to or before MR session 5 (day 5 or week 5, depending on type of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2018

Primary Completion (Anticipated)

February 1, 2025

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

May 1, 2018

First Submitted That Met QC Criteria

June 27, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18-5176

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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