MRI FDG PET Imaging Cervix
Conditions
Cervical Cancer Squamous Cell
Conditions: official terms
Neoplasms, Squamous Cell - Uterine Cervical Neoplasms
Conditions: Keywords
Cervical Cancer, PET Scan for cervix, MRI for cervix
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: 18-FDG PET/CT, DWI, DCE-MRI
Type: Biological
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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.
Location
University Health Network, The Princess Margaret
Toronto, Ontario, Canada
Status: Recruiting
Contact: Kathy Han, MD - 416 946 4501 - Kathy.Han@rmp.uhn.on.ca
Start Date
October 2012
Completion Date
October 2016
Sponsors
University Health Network, Toronto
Source
University Health Network, Toronto
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page