Back to resultsMRI (Including Spectroscopy and Fat-Saturations and Diffusion-Weighted Imaging) in Cervical Cancer (MRI)
Primary Purpose
Uterine Cervical Neoplasms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MR Spectroscopy
Fat-Saturation and Diffusion-Weighted Imaging
Dynamic Contrast Enhancement MRI (MR-DCE)
Diffusion Tensor Imaging (DTI)
Sponsored by
About this trial
This is an interventional device feasibility trial for Uterine Cervical Neoplasms focused on measuring Squamous cell cervical cancer
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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
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)
Outcomes
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.
Secondary Outcome Measures
Determine whether MR-DCE or MR-FS or DTI can improve target delineation in primary cervical tumors.
Full Information
NCT ID
NCT01060033
First Posted
January 28, 2010
Last Updated
April 12, 2017
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01060033
Brief Title
MRI (Including Spectroscopy and Fat-Saturations and Diffusion-Weighted Imaging) in Cervical Cancer
Acronym
MRI
Official Title
A Study of Novel Magnetic Resonance Imaging Sequences for Target Delineation and Prognostication in Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms
Keywords
Squamous cell cervical cancer
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
MR Spectroscopy
Intervention Type
Device
Intervention Name(s)
Fat-Saturation and Diffusion-Weighted Imaging
Intervention Type
Device
Intervention Name(s)
Dynamic Contrast Enhancement MRI (MR-DCE)
Intervention Type
Device
Intervention Name(s)
Diffusion Tensor Imaging (DTI)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Determine whether MR-DCE or MR-FS or DTI can improve target delineation in primary cervical tumors.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Esthappan, Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
MRI (Including Spectroscopy and Fat-Saturations and Diffusion-Weighted Imaging) in Cervical Cancer
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