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Clinical Trials/NCT01060033
NCT01060033
Completed
Not Applicable

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

Washington University School of Medicine1 site in 1 country9 target enrollmentNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uterine Cervical Neoplasms
Sponsor
Washington University School of Medicine
Enrollment
9
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
August 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Determine whether MR-DCE or MR-FS or DTI can improve target delineation in primary cervical tumors.(3 months)

Study Sites (1)

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