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MRI FDG PET Imaging Cervix

Primary Purpose

Cervical Cancer Squamous Cell

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
18-FDG PET/CT, DWI, DCE-MRI
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer Squamous Cell focused on measuring Cervical Cancer, PET Scan for cervix, MRI for cervix

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University Health Network, The Princess Margaret

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

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
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.

Secondary Outcome Measures

Follow-up imaging (MRI and 18FDG PET) versus the imaging done at the time of brachytherapy
Imaging techniques for visualizing the brachytherapy applicator.

Full Information

First Posted
October 23, 2012
Last Updated
November 7, 2022
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01899404
Brief Title
MRI FDG PET Imaging Cervix
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 3, 2012 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer Squamous Cell
Keywords
Cervical Cancer, PET Scan for cervix, MRI for cervix

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18-FDG PET/CT, DWI, DCE-MRI
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
18-FDG PET/CT, DWI, DCE-MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Target delineation using standard MRI acquired during the last week of EBRT fused to planning CT versus full MRI-guided brachytherapy.
Description
This objective will evaluate the potential for translation of this technique to centres with limited MRI access.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Follow-up imaging (MRI and 18FDG PET) versus the imaging done at the time of brachytherapy
Time Frame
2 years
Title
Imaging techniques for visualizing the brachytherapy applicator.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy Han, MD
Organizational Affiliation
University Health Network, The Princess Margaret
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, The Princess Margaret
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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MRI FDG PET Imaging Cervix

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