MRI FDG PET Imaging Cervix

NCT ID: NCT01899404

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-03
• Study Completion Date: 2016-12-31

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.

Conditions

Cervical Cancer Squamous Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18-FDG PET/CT, DWI, DCE-MRI

Group Type: EXPERIMENTAL

18-FDG PET/CT, DWI, DCE-MRI

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathy Han, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, The Princess Margaret

Locations

University Health Network, The Princess Margaret

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 12-5221-C

Identifier Type: -

Identifier Source: org_study_id