MRI FDG PET Imaging Cervix

Not Applicable

Completed

• Conditions: Cervical Cancer Squamous Cell
• Interventions: Biological: 18-FDG PET/CT, DWI, DCE-MRI

• Registration Number: NCT01899404
• Lead Sponsor: University Health Network, Toronto

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-03
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-15
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18-FDG PET/CT, DWI, DCE-MRI	18-FDG PET/CT, DWI, DCE-MRI	-

Primary Outcome Measures

Name	Time	Method
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.	2 years	This objective will evaluate the potential for translation of this technique to centres with limited MRI access.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Health Network, The Princess Margaret; 🇨🇦 Toronto, Ontario, Canada