Cervical Cancer Squamous Cell
Conditions
Keywords
Cervical Cancer, PET Scan for cervix, MRI for cervix
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.
Interventions
BIOLOGICAL18-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.
Sponsors
Princess Margaret Hospital, Canada
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
Canada
Outcome results
None listed