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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-08-31

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.

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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.

Conditions

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Uterine Cervical Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Arm 1

* 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)

Group Type OTHER

MR Spectroscopy

Intervention Type DEVICE

Fat-Saturation and Diffusion-Weighted Imaging

Intervention Type DEVICE

Dynamic Contrast Enhancement MRI (MR-DCE)

Intervention Type DEVICE

Diffusion Tensor Imaging (DTI)

Intervention Type DEVICE

Interventions

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MR Spectroscopy

Intervention Type DEVICE

Fat-Saturation and Diffusion-Weighted Imaging

Intervention Type DEVICE

Dynamic Contrast Enhancement MRI (MR-DCE)

Intervention Type DEVICE

Diffusion Tensor Imaging (DTI)

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No