PET-MRI Esophagus Feasibility Study

Not Applicable

Recruiting

• Conditions: Esophagogastric Cancer
• Interventions: Procedure: PET-MRI

• Registration Number: NCT05796102
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2023-03-21
• Study Start: 2023-03-28
• Study First Posted: 2023-04-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET-MRI	PET-MRI	PET-MRI in esophagogastric cancers

Primary Outcome Measures

Name	Time	Method
Feasibility of PET-MRI to visualize and assess impact of RT treatments on esophagogastric tumors	2 years	Detection of metastases on DWI and gadolinium enhanced T1-weighted 3D VIBE sequences.

Secondary Outcome Measures

Name	Time	Method
Difference in manual GTV segmentation using PET-MRI	2 years	Differences in manual GTV segmentation between standard of care treatment plan and study generated treatment plan using PET-MRI.
Quantification of dosimetric advantages of PET-MRI treatment plan	2 years	Comparison of dosimetry properties between the standard of care treatment plan and study generated treatment plan using PET-MRI.

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada