- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05796102
PET-MRI Esophagus Feasibility Study (PET-MRI)
Feasibility Study of PET-MRI as a Platform for Image Guidance and Adaptive Radiation Therapy in Patients With Esophagogastric Cancer
This is a single arm, single centre, investigator initiated study to investigate the feasibility of using PET-MRI imaging in radiation treatment workflow in up to 15 patients with esophagogastric cancer. PET-MRI imaging will be completed before the start of radiation treatment. MRI imaging will be completed during radiation treatment and after radiation treatment. These images will not be used to plan the radiation treatment and routine clinical care will be provided.
The goal of this study is to gather information that will allow the radiation team to include MRI and PET imaging into the radiation treatment workflow for patients with esophageal cancer receiving radiation therapy in the future.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rebecca K S Wong, MD
- Phone Number: 5736 4169462000
- Email: rebecca.wong@uhn.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Recruiting
- Princess Margaret Cancer Centre
-
Contact:
- Melissa Bartolo Rego
- Email: rmp.regulatory.affairs@rmp.uhn.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients 18 years or older
- Diagnosed with locally advanced esophageal cancer being considered for conventional RT >4 weeks
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Contraindication for MRI
- Contraindication for Gadolinium (i.e. inability to lie supine for at least 60 minutes)
- Any patient who is pregnant or breastfeeding
- Pacemaker or implanted defibrillator
- Claustrophobia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PET-MRI
PET-MRI in esophagogastric cancers
|
A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. Magnetic Resonance Imaging (MRI) provides better soft tissue contrast compared to conventional computerized tomography (CT), and when combined with PET, can potentially provide better visualization of the tumor shape, size, and position. Additional MRI imaging will be completed once during radiation treatment, and once after radiation treatment |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of PET-MRI to visualize and assess impact of RT treatments on esophagogastric tumors
Time Frame: 2 years
|
Detection of metastases on DWI and gadolinium enhanced T1-weighted 3D VIBE sequences.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in manual GTV segmentation using PET-MRI
Time Frame: 2 years
|
Differences in manual GTV segmentation between standard of care treatment plan and study generated treatment plan using PET-MRI.
|
2 years
|
|
Quantification of dosimetric advantages of PET-MRI treatment plan
Time Frame: 2 years
|
Comparison of dosimetry properties between the standard of care treatment plan and study generated treatment plan using PET-MRI.
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22-5780
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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