MRI FDG PET Imaging Cervix

NCT01899404 — Not applicable, Completed, 25 participants, University Health Network, Toronto

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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

Registry	NCT01899404
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	25 (Actual)
Sponsor	University Health Network, Toronto (Other); collaborators: Princess Margaret Hospital, Canada
Conditions	Cervical Cancer Squamous Cell
Interventions	18-FDG PET/CT, DWI, DCE-MRI (Biological)
Dates	start 2012-10-03, primary completion 2016-12-01, completion 2016-12-01, first posted 2013-07-15, last updated 2022-11-08
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
18-FDG PET/CT, DWI, DCE-MRI	Experimental	Biological: 18-FDG PET/CT, DWI, DCE-MRI

18-FDG PET/CT, DWI, DCE-MRI (Biological): 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.

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: Female, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
University Health Network, The Princess Margaret	Toronto, Ontario	Canada

+Investigators

Kathy Han, MD, Principal investigator, University Health Network, The Princess Margaret

My Notes

Public

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