MR Guidance for Liver and Pancreas

NCT03582189 | Recruiting

• 1 other identifier: 18-5176
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnetic Resonance Imaging

Keywords

Liver Cancer; Pancreatic Cancer; Radiation

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (3)

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

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

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

Interventions

MRI OTHER

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; Liver Metastases; Pancreatic Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Laura Dawson, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edel Sexton

CONTACT

416-946-4501; Edel.Sexton@uhn.ca

Jana Huang

CONTACT

Jana.Huang@uhnresearch.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: July 10, 2018
• Study Start: July 11, 2018
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CA (1)