PET-MRI Esophagus Feasibility Study

Esophagogastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796102
• Other study ID #: 22-5780
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: May 2025

Study information

• Verified date: April 2023
• Source: University Health Network, Toronto
• Contact: Cynthia Torres
• Phone: 416-946-4501
• Email: cynthia.torres[@]rmp.uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagogastric Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of PET-MRI to visualize and assess impact of RT treatments on esophagogastric tumors	Detection of metastases on DWI and gadolinium enhanced T1-weighted 3D VIBE sequences.	2 years
Secondary	Difference in manual GTV segmentation using PET-MRI	Differences in manual GTV segmentation between standard of care treatment plan and study generated treatment plan using PET-MRI.	2 years
Secondary	Quantification of dosimetric advantages of PET-MRI treatment plan	Comparison of dosimetry properties between the standard of care treatment plan and study generated treatment plan using PET-MRI.	2 years