Uterine Cervical NeoplasmsMRINCT01060033
MRI (Including Spectroscopy and Fat-Saturations and Diffusion-Weighted Imaging) in Cervical Cancer
A study testing MR Spectroscopy, Fat-Saturation and Diffusion-Weighted Imaging and Dynamic Contrast Enhancement MRI (MR-DCE) in people with Uterine Cervical Neoplasms, run by Washington University School of Medicine at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- MR Spectroscopy, Fat-Saturation and Diffusion-Weighted Imaging and Dynamic Contrast Enhancement MRI (MR-DCE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Study of Novel Magnetic Resonance Imaging Sequences for Target Delineation and Prognostication in Cervical Cancer
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.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- MR Spectroscopy, Fat-Saturation and Diffusion-Weighted Imaging, Dynamic Contrast Enhancement MRI (MR-DCE), Diffusion Tensor Imaging (DTI)
- Keywords
- Squamous cell cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR SpectroscopyDevice
Fat-Saturation and Diffusion-Weighted ImagingDevice
Dynamic Contrast Enhancement MRI (MR-DCE)Device
Diffusion Tensor Imaging (DTI)Device
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | * 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) Receives: Device: MR Spectroscopy; Device: Fat-Saturation and Diffusion-Weighted Imaging; Device: Dynamic Contrast Enhancement MRI (MR-DCE); Device: Diffusion Tensor Imaging (DTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Determine whether MR-DCE or MR-FS or DTI can improve target delineation in primary cervical tumors.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacqueline Esthappan, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060033
- Sponsor's protocol ID
- 10-0033 / 201109278
- Acronym
- MRI
- Status last verified
- Apr 2017
- First submitted
- 28 Jan 2010
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Novel Magnetic Resonance Imaging Sequences for Target Delineation and Prognostication in Cervical Cancer
- ClinicalTrials.gov ID
- NCT01060033
- Acronym / sponsor ID
- MRI / 10-0033 / 201109278
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Squamous cell cervical cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Device: MR Spectroscopy, Device: Fat-Saturation and Diffusion-Weighted Imaging, Device: Dynamic Contrast Enhancement MRI (MR-DCE), Device: Diffusion Tensor Imaging (DTI)* 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR Spectroscopy | Device | Arm 1 |
| Fat-Saturation and Diffusion-Weighted Imaging | Device | Arm 1 |
| Dynamic Contrast Enhancement MRI (MR-DCE) | Device | Arm 1 |
| Diffusion Tensor Imaging (DTI) | Device | Arm 1 |
Primary outcome
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
1 secondary outcome
Determine whether MR-DCE or MR-FS or DTI can improve target delineation in primary cervical tumors.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Esthappan, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Spectroscopy, Fat-Saturation and Diffusion-Weighted Imaging and Dynamic Contrast Enhancement MRI (MR-DCE) in people with Uterine Cervical Neoplasms, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.