NCT01899404

Brief 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. 1.special types of MRI called diffusion weighted MRI (DWI) and dynamic-contrast enhanced MRI (DCE-MRI); and
  2. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

4.2 years

First QC Date

October 23, 2012

Last Update Submit

November 7, 2022

Conditions

Cervical Cancer Squamous Cell

Keywords

Cervical CancerPET Scan for cervixMRI for cervix

Outcome Measures

Primary Outcomes (2)

  • 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

    2 years

  • 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.

    2 years

Secondary Outcomes (2)

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

    2 years

  • Imaging techniques for visualizing the brachytherapy applicator.

    2 years

Study Arms (1)

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

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

Interventions

18-FDG PET/CT, DWI, DCE-MRIBIOLOGICAL

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.

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

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix
  • FIGO Stage IB - IVA
  • Intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the PMH Gynecology Group
  • Intention to treat with MR-guided brachytherapy as part of standard radiotherapy according to the current treatment policies of the PMH Gynecology Group
  • No cytotoxic anti-cancer therapy for cervix cancer prior to study entry
  • 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
  • Ability to provide written informed consent to participate in the study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, The Princess Margaret

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Kathy Han, MD

    University Health Network, The Princess Margaret

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 23, 2012

First Posted

July 15, 2013

Study Start

October 3, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 8, 2022

Record last verified: 2022-11

Locations

CA(1)