MR Guidance for Liver and Pancreas

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT03582189
Collaborator
(none)
30
1
48.8
0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: MRI

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Jul 11, 2018
Anticipated Primary Completion Date :
Aug 3, 2022
Anticipated Study Completion Date :
Aug 3, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Patient Satisfaction Survey [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

  2. MRI-Anxiety Questionnaire [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

  3. MRI-Anxiety Questionnaire [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

  4. MRI-Anxiety Questionnaire [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

  5. MRI-Anxiety Questionnaire [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

  6. MRI-Anxiety Questionnaire [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Health Network - Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Laura Dawson, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT03582189
Other Study ID Numbers:
  • 18-5176
First Posted:
Jul 10, 2018
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Health Network, Toronto

Study Results

No Results Posted as of Oct 6, 2021