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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study of Novel Magnetic Resonance Imaging Sequences for Target Delineation and Prognostication in Cervical Cancer

Conditions
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Uterine Cervical Neoplasms

Intervention / Treatment
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* Device: MR Spectroscopy
* Device: Fat-Saturation and Diffusion-Weighted Imaging
* Device: Dynamic Contrast Enhancement MRI (MR-DCE)
* Device: Diffusion Tensor Imaging (DTI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>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) | Device: MR Spectroscopy<br> <br> Device: Fat-Saturation and Diffusion-Weighted Imaging<br> <br> Device: Dynamic Contrast Enhancement MRI (MR-DCE)<br> <br> Device: Diffusion Tensor Imaging (DTI)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether MR-DCE or MR-FS or DTI can improve target delineation in primary cervical tumors. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Squamous cell cervical cancer