Clinical trial NCT03582189: MR Guidance for Liver and Pancreas
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Magnetic Resonance Imaging
Keywords: Liver Cancer
Pancreatic Cancer
Radiation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient Satisfaction Survey
timeFrame: At study completion (day5 or week 5, depending on type of treatment)
measure: MRI-Anxiety Questionnaire
timeFrame: Prior to or before MR session 1 (day 1 or week 1, depending on type of treatment)
measure: MRI-Anxiety Questionnaire
timeFrame: Prior to or before MR session 2 (day 2 or week 2, depending on type of treatment)
measure: MRI-Anxiety Questionnaire
timeFrame: Prior to or before MR session 3 (day 3 or week 3, depending on type of treatment)
measure: MRI-Anxiety Questionnaire
timeFrame: Prior to or before MR session 4 (day 4 or week 4, depending on type of treatment)
measure: MRI-Anxiety Questionnaire
timeFrame: Prior to or before MR session 5 (day 5 or week 5, depending on type of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Laura Dawson, MD
role: PRINCIPAL_INVESTIGATOR
References: