MRI FDG PET Imaging Cervix

November 7, 2022 updated by: University Health Network, Toronto

A Pilot Prospective Study of the Utility of Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI), Diffusion Weighted MRI (DWI)and Positron Emission Tomography (PET) Imaging With 18F-Fluorodeoxyglucose (18FDG) in Brachytherapy for Cervix Cancer

The standard treatment for cervix cancer at Princess Margaret Hospital is external radiation with chemotherapy followed by internal radiation, called brachytherapy. Currently, brachytherapy treatment is planned on a type of Magnetic Resonance Imaging (MRI) called T2-weighted (T2W) MRI.

The main purpose of this study is to determine whether the following imaging tests can visualize the tumor better for planning the brachytherapy treatment:

  1. special types of MRI called diffusion weighted MRI (DWI) and dynamic-contrast enhanced MRI (DCE-MRI); and
  2. an x-ray test called positron emission test (PET) performed with a sugar dye called FDG. MRI-guided brachytherapy is resource-intensive and not widely available.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network, The Princess Margaret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix
  3. FIGO Stage IB - IVA
  4. Intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the PMH Gynecology Group
  5. Intention to treat with MR-guided brachytherapy as part of standard radiotherapy according to the current treatment policies of the PMH Gynecology Group
  6. No cytotoxic anti-cancer therapy for cervix cancer prior to study entry
  7. A negative urine or serum pregnancy test within the two week interval immediately prior to the first PET-CT imaging, in women of child-bearing age
  8. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  1. Prior complete or partial hysterectomy
  2. Carcinoma of the cervical stump
  3. Inability to lie supine for more than 30 minutes
  4. Insulin-dependent diabetes mellitus
  5. Impaired kidney function with glomerular filtration rate < 30
  6. Previous anaphylactic reaction to gadolinium or other contraindications to MR.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18-FDG PET/CT, DWI, DCE-MRI
Biological: 18-FDG PET/CT, DWI, DCE-MRI
All patients on this study will receive a Diffuse Weighted MRI and Dynamic Contrast Enhancing MRI during the routine MRI session on the day of brachytherapy (additional 10 minutes), and a FDG PET/CT scanning session on the day of brachytherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target delineation in brachytherapy using standard T2-weighted MRI versus DCE-MRI, DWI and FDG-PET/CT imaging: gross tumor volume and high-risk clinical target volume in patients with cervical cancer
Time Frame: 2 years
2 years
Target delineation using standard MRI acquired during the last week of EBRT fused to planning CT versus full MRI-guided brachytherapy.
Time Frame: 2 years
This objective will evaluate the potential for translation of this technique to centres with limited MRI access.
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Follow-up imaging (MRI and 18FDG PET) versus the imaging done at the time of brachytherapy
Time Frame: 2 years
2 years
Imaging techniques for visualizing the brachytherapy applicator.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Kathy Han, MD, University Health Network, The Princess Margaret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 12-5221-C

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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