MRI FDG PET Imaging Cervix

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cervical Cancer Squamous Cell

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18-FDG PET/CT, DWI, DCE-MRI<br> | Biological: 18-FDG PET/CT, DWI, DCE-MRI<br>* 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.<br>|

What is the study measuring?
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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 |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Cancer, PET Scan for cervix, MRI for cervix