MR Guidance for Liver and Pancreas
ConditionMagnetic Resonance Imaging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI
Other interventionPatients 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
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Pancreatic Cancer1 intervention
Group B: Liver Metastases1 intervention
Group C: Hepatocellular carcinoma1 intervention
Trial outcomes
Primary outcomes
1
Patient Satisfaction Survey
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
Time frame
At study completion (day5 or week 5, depending on type of treatment)2
MRI-Anxiety Questionnaire
This instrument will be used to evaluate patient related anxiety after each MR
Time frame
Prior to or before MR session 1 (day 1 or week 1, depending on type of treatment)3
MRI-Anxiety Questionnaire
This instrument will be used to evaluate patient related anxiety after each MR
Time frame
Prior to or before MR session 2 (day 2 or week 2, depending on type of treatment)4
MRI-Anxiety Questionnaire
This instrument will be used to evaluate patient related anxiety after each MR
Time frame
Prior to or before MR session 3 (day 3 or week 3, depending on type of treatment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov