Clinical trial NCT01899404: MRI FDG PET Imaging Cervix
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer Squamous Cell
Keywords: Cervical Cancer
PET Scan for cervix
MRI for cervix
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2013-07-15
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 2 years
measure: Target delineation using standard MRI acquired during the last week of EBRT fused to planning CT versus full MRI-guided brachytherapy.
timeFrame: 2 years
Secondary outcomes:
measure: Follow-up imaging (MRI and 18FDG PET) versus the imaging done at the time of brachytherapy
timeFrame: 2 years
measure: Imaging techniques for visualizing the brachytherapy applicator.
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, The Princess Margaret
state: Ontario
Study officials:
affiliation: University Health Network, The Princess Margaret
name: Kathy Han, MD
role: PRINCIPAL_INVESTIGATOR
References: