ClinicalTrials.gg
CompletedNCT01060033MRIUpdated Apr 14, 2017

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

An interventional study of MR Spectroscopy and Fat-Saturation and Diffusion-Weighted Imaging in Uterine Cervical Neoplasms, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-14.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Uterine Cervical Neoplasms

Keywords

  • Squamous cell cervical cancer
03

In context

Uterine Cervical Neoplasms

1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.

This study's enrollment of 9 is below the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 271 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Other
    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)

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

Interventions

  • DeviceMR Spectroscopy
  • DeviceFat-Saturation and Diffusion-Weighted Imaging
  • DeviceDynamic Contrast Enhancement MRI (MR-DCE)
  • DeviceDiffusion Tensor Imaging (DTI)
06

What researchers measure

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

07

Study locations

1 site
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01060033
Responsible party
Sponsor
First posted
Feb 1, 2010
Start date
Nov 2010
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Apr 14, 2017

Study contacts

Jacqueline Esthappan, Ph.D.
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion