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OpenTrials
Completed

NCT Number: NCT01060033

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MR Spectroscopy

Device

Fat-Saturation and Diffusion-Weighted Imaging

Device

Dynamic Contrast Enhancement MRI (MR-DCE)

Device

Diffusion Tensor Imaging (DTI)

Device

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. Determine whether MR-DCE or MR-FS or DTI can improve target delineation in primary cervical tumors.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: MRI

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 1, 2010
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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