MRI FDG PET Imaging Cervix

Cervical Cancer Squamous Cell Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899404
• Other study ID #: UHN REB 12-5221-C
• Status: Completed
• Phase: N/A
• Start date: October 3, 2012
• Est. completion date: December 2016

Study information

• Verified date: November 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer Squamous Cell
• Uterine Cervical Neoplasms

Intervention

Biological:
• 18-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.

Locations

Country	Name	City	State
Canada	University Health Network, The Princess Margaret	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Follow-up imaging (MRI and 18FDG PET) versus the imaging done at the time of brachytherapy		2 years
Secondary	Imaging techniques for visualizing the brachytherapy applicator.		2 years