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

This study is currently recruiting participants.
Verified March 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01060033
First received: January 28, 2010
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Uterine Cervical Neoplasms
 Other: MR spectroscopy and (DCE) MR imaging
 Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Study of Novel Magnetic Resonance Imaging Sequences for Target Delineation and Prognostication in Cervical Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The primary objective is 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective is to determine whether MR-DCE or MR-FS can improve target delineation in primary cervical tumors. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MR spectroscopy and (DCE) MR imaging
MR spectroscopy, diffusion weighted MR, diffusion tensor imaging, and dynamic contrast enhancement (DCE) MR imaging
 Other: MR spectroscopy and (DCE) MR imaging
MR spectroscopy, diffusion weighted MR, diffusion tensor imaging (DTI), and dynamic contrast enhancement (DCE) MR imaging

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060033

Contacts
Contact: Jacqueline Esthappan 314-747-9548 jesthappan@radonc.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jacqueline Esthappan, PHD     314-747-9548     jesthappan@radonc.wustl.edu    
Sub-Investigator: Daniel Ma, M.D.            
Sub-Investigator: Isreal Zighelboim, M.D.            
Sub-Investigator: Andrea Roma, M.D.            
Sub-Investigator: Vamsi Narra, M.D.            
Sub-Investigator: Perry W Grigsby, M.D.            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jacqueline Esthappan Washington University School of Medicine
  More Information

Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01060033     History of Changes
Other Study ID Numbers: 10-0033 / 201109278
Study First Received: January 28, 2010
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Squamous cell cervical cancer

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013