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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 2, 2014
Last verified: May 2014
  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
Other: Fat-Saturation and Diffusion-Weighted Imaging
Other: Dynamic Contrast Enhancement MRI (MR-DCE)
Other: Diffusion Tensor Imaging (DTI)
Phase 1
Phase 2

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:


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

Primary Outcome Measures:
  • 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:
  • Determine whether MR-DCE or MR-FS or DTI can improve target delineation in primary cervical tumors. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other: MR Spectroscopy Other: Fat-Saturation and Diffusion-Weighted Imaging Other: Dynamic Contrast Enhancement MRI (MR-DCE) Other: Diffusion Tensor Imaging (DTI)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060033

Contacts
Contact: Jacqueline Esthappan, Ph.D. 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, Ph.D.    314-747-9548    jesthappan@radonc.wustl.edu   
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, Ph.D. Washington University School of Medicine
  More Information

Additional Information:
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: May 2, 2014
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 July 29, 2014