Uterine FibroidsMRENCT01229826
Magnetic Resonance Elastography (MRE) of Uterine Fibroids
An observational study of Uterine Fibroids, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to gain additional information regarding use of Magnetic Resonance Elastography (MRE) for uterine fibroid characterization. In this study, the investigators will use a new noninvasive technology, MRE, to further characterize the elastic properties of the uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- MR Elastography
- Type of treatment
- Surgery or procedure
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2015
- Phase
- Observational
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female individuals between the years of 18 and 65 whose doctor has suggested magentic resonance imaging of the uterus for treatment of uterine fibroids.
Who may be able to join
- Women able to give informed consent
- Women having uterine imaging
Who cannot join
- Women currently pregnant
- Allergy to either gadolinium or iodinated contrast
- Severe claustrophobia
- Weight in excess of 250 pounds
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to gain additional information regarding use of Magnetic Resonance Elastography (MRE) for uterine fibroid characterization. In this study, the investigators will use a new noninvasive technology, MRE, to further characterize the elastic properties of the uterine fibroids. To date, very little is known concerning how the tissue composition of the uterine fibroid may affect its treatment with Magnetic Resonance Guided Focused Ultrasound (MRgFUS).
In this study, the investigators will use a new noninvasive technology, magnetic resonance elastography (MRE), to further characterize the elastic properties of the uterine fibroids. This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids. It is known that some fibroids with increased T2-signal on Magnetic Resonance Imaging(MRI) can be more difficult to treat.
This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids.
Read the detailed description
This is a single-site, non-randomized pilot study to determine whether Magnetic Resonance Elastography (MRE) can be optimized for clinical use as part of the patients routine clinical imaging and to correlate with MR signal characteristics of the uterine fibroid.
MRE is performed at the end of the examination after the standard Magnetic Resonance Imaging protocol.
Aims:
Specific Aim 1: To acquire magnetic resonance elastography images on women who have a clinically ordered pelvic magnetic resonance imaging (MRI) for uterine fibroids.
Specific Aim 2: To examine the correlation between MRE stiffness values and MR T2 signal characteristics for uterine fibroids. For a subset of patients going on to surgery correlation with pathology can also be performed.
This study will seek to determine whether MRE can be performed in the pelvis on a routine clinical basis as well as correlating the MRE findings with magnetic resonance signal characteristics. There are no additional risks to the patient and no additional cost to the MRI exam.
- Conditions
- Uterine Fibroids
- Being tested
- MR Elastography
- Keywords
- Uterine fibroids, Uterine leiomyomas, MR Elastography, MRI (Magnetic Resonance Imaging), Symptomatic Uterine Fibroids
- Medical subject headings
- Leiomyoma, Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR ElastographyRadiation
Also called Signa, GE Healthcare
MRE is performed at the end of the examination after the standard MRI protocol. A test vibration is first applied on the patient to familiarize the patient with the vibration. The MRE sequence is performed with either a body coil or a pelvic-array coil. The total acquisition time is split into four periods of suspended respiration of 16 seconds for acquisition of wave images at four phase offsets. To obtain a consistent position of the fibroid for each phase offset, patients are asked to quietly breath and remain still.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of MR elastography images for comparison.
MRE is performed at the end of the examination after the standard Magnetic Resonance Imaging(MRI) protocol.
Measured: every six months
Secondary outcomes (1)
Examination of Magnetic Resonance Elastography stiffness values and MR T2.
To examine the correlation between MR elastography stiffness values and MR T2 signal characteristics for uterine fibroids. For a subset of patients going on to surgery correlation with pathology can also be performed.
Measured: every six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Woodrum, Mayo Clinic
- Investigators
- David A. Woodrum, M.D., PhD., Principal investigator, Mayo Clinic - Rochester, Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229826
- Sponsor's protocol ID
- 10-002112
- Other IDs
- Mayo Clinic
- Acronym
- MRE
- Status last verified
- Sep 2015
- First submitted
- 22 Oct 2010
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Elastography (MRE) of Uterine Fibroids
- ClinicalTrials.gov ID
- NCT01229826
- Acronym / sponsor ID
- MRE / 10-002112
- Conditions
- Uterine Fibroids
- Keywords
- Uterine fibroids, Uterine leiomyomas, MR Elastography, MRI (Magnetic Resonance Imaging), Symptomatic Uterine Fibroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Oct 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.
The purpose of this study is to gain additional information regarding use of Magnetic Resonance Elastography (MRE) for uterine fibroid characterization. In this study, the investigators will use a new noninvasive technology, MRE, to further characterize the elastic properties of the uterine fibroids. To date, very little is known concerning how the tissue composition of the uterine fibroid may affect its treatment with Magnetic Resonance Guided Focused Ultrasound (MRgFUS).
In this study, the investigators will use a new noninvasive technology, magnetic resonance elastography (MRE), to further characterize the elastic properties of the uterine fibroids. This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids. It is known that some fibroids with increased T2-signal on Magnetic Resonance Imaging(MRI) can be more difficult to treat.
This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids.
Detailed description
This is a single-site, non-randomized pilot study to determine whether Magnetic Resonance Elastography (MRE) can be optimized for clinical use as part of the patients routine clinical imaging and to correlate with MR signal characteristics of the uterine fibroid.
MRE is performed at the end of the examination after the standard Magnetic Resonance Imaging protocol.
Aims:
Specific Aim 1: To acquire magnetic resonance elastography images on women who have a clinically ordered pelvic magnetic resonance imaging (MRI) for uterine fibroids.
Specific Aim 2: To examine the correlation between MRE stiffness values and MR T2 signal characteristics for uterine fibroids. For a subset of patients going on to surgery correlation with pathology can also be performed.
This study will seek to determine whether MRE can be performed in the pelvis on a routine clinical basis as well as correlating the MRE findings with magnetic resonance signal characteristics. There are no additional risks to the patient and no additional cost to the MRI exam.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female individuals between the years of 18 and 65 whose doctor has suggested magentic resonance imaging of the uterus for treatment of uterine fibroids.
Key inclusion criteria (2 listed)
- Women able to give informed consent
- Women having uterine imaging
Key exclusion criteria (4 listed)
- Women currently pregnant
- Allergy to either gadolinium or iodinated contrast
- Severe claustrophobia
- Weight in excess of 250 pounds
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 ElastographyAlso: Signa, GE HealthcareMRE is performed at the end of the examination after the standard MRI protocol. A test vibration is first applied on the patient to familiarize the patient with the vibration. The MRE sequence is performed with either a body coil or a pelvic-array coil. The total acquisition time is split into four periods of suspended respiration of 16 seconds for acquisition of wave images at four phase offsets. To obtain a consistent position of the fibroid for each phase offset, patients are asked to quietly breath and remain still. | Radiation | – |
Primary outcome
Acquisition of MR elastography images for comparison.
Time frame: every six months
MRE is performed at the end of the examination after the standard Magnetic Resonance Imaging(MRI) protocol.
1 secondary outcome
Examination of Magnetic Resonance Elastography stiffness values and MR T2.
Time frame: every six 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 2 Sep 2015.
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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.
David A. Woodrum, M.D., PhD. principal investigator
Mayo Clinic - Rochester, Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids, run by Mayo Clinic 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 2 inclusion and 4 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 2 Sep 2015. 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?
Acquisition of MR elastography images for comparison. (time frame: every six 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 2 Sep 2015.