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MR Guidance for Liver and Pancreas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03582189
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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
Magnetic Resonance Imaging Other: MRI

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Study Type : Observational
Estimated 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 : July 11, 2018
Estimated Primary Completion Date : August 3, 2022
Estimated Study Completion Date : August 3, 2022

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Patient Satisfaction Survey [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582189


Contacts
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Contact: Mahesh Kajil 416-946-4501 ext 2434 mahesh.kajil@rmp.uhn.ca
Contact: Lea Dungao lea.dungao@rmp.uhn.ca

Locations
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Canada, Ontario
University Health Network - Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Laura Dawson, MD         
Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03582189    
Other Study ID Numbers: 18-5176
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020

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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:
Liver Cancer
Pancreatic Cancer
Radiation