MRI FDG PET Imaging Cervix

This study is currently recruiting participants.
Verified July 2013 by University Health Network, Toronto
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01899404
First received: October 23, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.

Condition Intervention
Cervical Cancer Squamous Cell
Biological: 18-FDG PET/CT, DWI, DCE-MRI

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    This objective will evaluate the potential for translation of this technique to centres with limited MRI access.


Secondary Outcome Measures:
  • Follow-up imaging (MRI and 18FDG PET) versus the imaging done at the time of brachytherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Imaging techniques for visualizing the brachytherapy applicator. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01899404

Contacts
Contact: Michael Milosevic, MD 416 946 4501 ext 2932 Michael.Milosevic@rmp.uhn.on.ca
Contact: Kathy Han, MD 416 946 4501 ext 2919 Kathy.Han@rmp.uhn.on.ca

Locations
Canada, Ontario
University Health Network, The Princess Margaret Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Michael Milosevic, MD    416 946 4501 ext 2932    Michael.Milosevic@rmp.uhn.on.ca   
Contact: Kathy Han, MD    416 946 4501 ext 2919    Kathy.Han@rmp.uhn.on.ca   
Principal Investigator: Michael Milosevic, MD         
Sub-Investigator: Anthony Fyles, MD         
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Michael Milosevic, MD University Health Network, The Princess Margaret
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01899404     History of Changes
Other Study ID Numbers: UHN REB 12-5221-C
Study First Received: October 23, 2012
Last Updated: July 10, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Cervical Cancer
PET Scan for cervix
MRI for cervix

Additional relevant MeSH terms:
Uterine Cervical Diseases
Uterine Cervical Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 16, 2014