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

The Washington University

Status: Completed

Conditions: Uterine Cervical Neoplasms

Treatments: Device: Dynamic Contrast Enhancement MRI (MR-DCE); Device: Fat-Saturation and Diffusion-Weighted Imaging; Device: Diffusion Tensor Imaging (DTI); Device: MR Spectroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01060033

10-0033 / 201109278

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Arm 1

Other group

Description:

* 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)

Treatment:

Device: Fat-Saturation and Diffusion-Weighted Imaging

Device: Diffusion Tensor Imaging (DTI)

Device: MR Spectroscopy

Device: Dynamic Contrast Enhancement MRI (MR-DCE)