PET-MRI Esophagus Feasibility Study

Sponsor

University Health Network, Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT05796102

Collaborator

(none)

Enrollment

Location

Arm

25.1

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophagogastric Cancer	Procedure: PET-MRI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Feasibility Study of PET-MRI as a Platform for Image Guidance and Adaptive Radiation Therapy in Patients With Esophagogastric Cancer

Actual Study Start Date :

Mar 28, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PET-MRI PET-MRI in esophagogastric cancers	Procedure: PET-MRI 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

Arm

Intervention/Treatment

Experimental: PET-MRI

PET-MRI in esophagogastric cancers

Procedure: PET-MRI

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Centre	Toronto	Ontario	Canada

Sponsors and Collaborators

University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT05796102

Other Study ID Numbers:

22-5780

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 6, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 6, 2023