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2018-07-11
2027-02
2027-02
30
NCT03582189
University Health Network, Toronto
University Health Network, Toronto
OBSERVATIONAL
MR Guidance for Liver and Pancreas
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.
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These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-05-01 | N/A | 2024-06-17 |
2018-06-27 | N/A | 2024-06-18 |
2018-07-10 | N/A | 2024-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | 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
|
| : 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Edel Sexton Phone Number: 416-946-4501 Email: Edel.Sexton@uhn.ca |
Study Contact Backup Name: Jana Huang Phone Number: Email: Jana.Huang@uhnresearch.ca |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
