MRI (Including Spectroscopy and Fat-Saturations and Diffusion-Weighted Imaging) in Cervical Cancer

Not Applicable

Completed

• Conditions: Uterine Cervical Neoplasms
• Interventions: Device: MR Spectroscopy; Device: Fat-Saturation and Diffusion-Weighted Imaging; Device: Dynamic Contrast Enhancement MRI (MR-DCE); Device: Diffusion Tensor Imaging (DTI)

• Registration Number: NCT01060033
• Lead Sponsor: Washington University School of Medicine

Brief Summary

To detect differences in MR spectroscopy, diffusion weighted MR, diffusion tensor imaging (DTI) or dynamic contrast enhancement (DCE) MR imaging between primary cervical tumors and normal cervical tissue.

Detailed Description

At our institution, all patients receiving external beam and/or brachytherapy as part of the treatment of primary cervical cancer receive CT, PET, and MRI simulation scans as standard of care. Brachytherapy patients also receive weekly T1/T2 weighted MR simulation scans as part of their treatment planning.

We propose the use of additional MR sequences to the standard T1/T2 weighted MR simulation scans. The data obtained from these additional sequences will be used for improving tumor delineation and obtaining prognostic information.

Study Timeline

• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-01-29
• Study First Posted: 2010-02-01
• Study Start: 2010-11
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Patients must have biopsy-proven newly diagnosed squamous cell cervical cancer (FIGO clinical stages IB2-IVA).
• Patients must be ≥ 18 years of age.
• Patients must be able to receive standard radiation therapy (external beam radiation and brachytherapy) with or without chemotherapy.
• Patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least one year.
• Patients must be scheduled to undergo or have already undergone FDG-PET/CT imaging for clinical staging cervical cancer at Barnes-Jewish Hospital Clinical PET facility on the Siemens Biograph 40 True Point Tomograph Scanner or elsewhere in the WUSM Nuclear Medicine department using the quality controls instituted by Nuclear Medicine.
• Patients must be able to give informed consent.

Exclusion Criteria

• Patients with another known active malignancy.
• Patients who have received treatment for any malignancy (with the exception of non-melanoma skin cancer) in the past 5 years.
• Pregnant or breastfeeding patients.
• Patients whose tumors are not FDG avid on baseline standard of care FDG-PET/CT imaging.
• Patients with contraindications to MRI scanning.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	MR Spectroscopy	* Clinical T1/T2-weighted MRI sequence per standard of care before treatment, during treatment per standard protocol, and at 3 months. * Patients may have one or all of the following sequences in addition to the standard MRI imaging: * MR Spectroscopy * Fat-saturation and Diffusion-Weighted Imaging * Dynamic Contrast Enhancement MRI (MR-DCE) * Diffusion Tensor Imaging (DTI)
Arm 1	Fat-Saturation and Diffusion-Weighted Imaging	* Clinical T1/T2-weighted MRI sequence per standard of care before treatment, during treatment per standard protocol, and at 3 months. * Patients may have one or all of the following sequences in addition to the standard MRI imaging: * MR Spectroscopy * Fat-saturation and Diffusion-Weighted Imaging * Dynamic Contrast Enhancement MRI (MR-DCE) * Diffusion Tensor Imaging (DTI)
Arm 1	Dynamic Contrast Enhancement MRI (MR-DCE)	* Clinical T1/T2-weighted MRI sequence per standard of care before treatment, during treatment per standard protocol, and at 3 months. * Patients may have one or all of the following sequences in addition to the standard MRI imaging: * MR Spectroscopy * Fat-saturation and Diffusion-Weighted Imaging * Dynamic Contrast Enhancement MRI (MR-DCE) * Diffusion Tensor Imaging (DTI)
Arm 1	Diffusion Tensor Imaging (DTI)	* Clinical T1/T2-weighted MRI sequence per standard of care before treatment, during treatment per standard protocol, and at 3 months. * Patients may have one or all of the following sequences in addition to the standard MRI imaging: * MR Spectroscopy * Fat-saturation and Diffusion-Weighted Imaging * Dynamic Contrast Enhancement MRI (MR-DCE) * Diffusion Tensor Imaging (DTI)

Primary Outcome Measures

Name	Time	Method
Differences in MR spectroscopy, diffusion weighted MR, diffusion tensor imaging (DTI) or dynamic contrast enhancement (DCE) MR imaging between primary cervical tumors and normal cervical tissue.	3 months

Secondary Outcome Measures

Name	Time	Method
Determine whether MR-DCE or MR-FS or DTI can improve target delineation in primary cervical tumors.	3 months

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States