NCT05796102

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Mar 2023May 2027

First Submitted

Initial submission to the registry

December 9, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

December 9, 2022

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Difference in manual GTV segmentation using PET-MRI

    2 years

  • Quantification of dosimetric advantages of PET-MRI treatment plan

    2 years

Study Arms (1)

PET-MRI

EXPERIMENTAL

PET-MRI in esophagogastric cancers

Procedure: PET-MRI

Interventions

PET-MRIPROCEDURE

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

PET-MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

RECRUITING

Central Study Contacts

Rebecca K S Wong, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2022

First Posted

April 3, 2023

Study Start

March 28, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations