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CompletedNCT01899404Updated Nov 8, 2022

MRI FDG PET Imaging Cervix

An interventional study of 18-FDG PET/CT, DWI, DCE-MRI in Cervical Cancer Squamous Cell, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study summary

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.
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Conditions studied

  • Cervical Cancer Squamous Cell

Keywords

  • Cervical Cancer
  • PET Scan for cervix
  • MRI for cervix
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 25 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    18-FDG PET/CT, DWI, DCE-MRI

    Biological: 18-FDG PET/CT, DWI, DCE-MRI

Interventions

  • Biological18-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.

06

What researchers measure

Primary outcomes

  1. 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. Target delineation using standard MRI acquired during the last week of EBRT fused to planning CT versus full MRI-guided brachytherapy.

    This objective will evaluate the potential for translation of this technique to centres with limited MRI access.

    Time frame: 2 years

Secondary outcomes

  1. Follow-up imaging (MRI and 18FDG PET) versus the imaging done at the time of brachytherapy

    Time frame: 2 years

  2. Imaging techniques for visualizing the brachytherapy applicator.

    Time frame: 2 years

07

Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01899404
Lead sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
Responsible party
Sponsor
First posted
Jul 15, 2013
Start date
Oct 3, 2012
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Nov 8, 2022

Study contacts

Kathy Han, MD
principal investigator · University Health Network, The Princess Margaret

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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