MR Guidance for Liver and Pancreas

Magnetic Resonance Imaging Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03582189
• Other study ID #: 18-5176
• Status: Recruiting
• Start date: July 11, 2018
• Est. completion date: February 2027

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: Edel Sexton
• Phone: 416-946-4501
• Email: Edel.Sexton[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network - Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At study completion (day5 or week 5, depending on type of treatment)
Primary	MRI-Anxiety Questionnaire	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)
Primary	MRI-Anxiety Questionnaire	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)
Primary	MRI-Anxiety Questionnaire	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)
Primary	MRI-Anxiety Questionnaire	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)
Primary	MRI-Anxiety Questionnaire	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)