Uterine BleedingEarly Phase 1NCT01992718
What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
A Early Phase 1 study testing Evaluation of MRI, US for pelvic and uterine conditions and Patient preference between MRI and Ultrasound in people with Uterine Bleeding and Uterine Fibroids, run by University of Michigan at 1 site in United States.
Trial summary
To improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging), ultrasound and ultrasound with elastography). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Bleeding, Uterine Fibroids, Adenomyosis
- What is being tested?
- Evaluation of MRI, US for pelvic and uterine conditions and Patient preference between MRI and Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Mar 2018
- Phase
- Early Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Pelvic pain and/or abnormal uterine bleeding. (this is specific for Arm. 1 of this study)
- If you have had or are scheduled to have both a pelvic MRI (magnetic resonance imaging) and a pelvic ultrasound with 6 months of the time of enrollment. (this is specific to Arm 2 of this study).
- -
Who cannot join
- If you are post-menopausal(have not had a period in at least one year's time).
- If you have been diagnosed with gynecological malignancy such as uterine, endometrial, cervical or ovarian cancer.
- If you are unable or unwilling to sign the informed consents
- If you are unable to undergo the research study exams -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
To improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging), ultrasound and ultrasound with elastography).
Read the detailed description
Currently benign conditions of the uterus are frequently underdiagnosed or misdiagnosed. This project will help determine which diagnostic radiology exams are most helpful to the clinician in providing accurate diagnosis. In addition, this study will evaluate which exam (MRI vs. Ultrasound) patients prefer over another exam.
- Conditions
- Uterine Bleeding, Uterine Fibroids, Adenomyosis
- Being tested
- Evaluation of MRI, US for pelvic and uterine conditions, Patient preference between MRI and Ultrasound
- Medical subject headings
- Uterine Hemorrhage, Leiomyoma, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of MRI, US for pelvic and uterine conditionsProcedure or surgery
Pelvic ultrasound with transabdominal and transvaginal imaging. The transvaginal ultrasound will include elastography (TVUS-E). Also, a pelvic MRI will be performed if not done in the last 6 months. The MRI is performed with IV gadolinium-based contrast (MultiHance ®).
A patient survey will be included.
Patient preference between MRI and UltrasoundProcedure or surgery
Subjects may take part in this arm because they have recently had a MRI performed and scheduled for, or have recently undergone a pelvic ultrasound.
Subjects will also be asked to complete a survey that will state their preference with regards to examination/imaging. This will be done over the phone and will take no longer than 30 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of MRI, US for pelvic conditions | Active comparator | MRI and ultrasound imaging will be used clinically to evaluate pelvic pain and abnormal uterine bleeding. The goal is to determine which exams are most helpful to the clinician in providing an accurate diagnosis as well as evaluating patient preference. Receives: Procedure: Evaluation of MRI, US for pelvic and uterine conditions |
| Patient preference MRI vs. US | Active comparator | We are asking subjects to evaluate patient preference between MRI (magnetic resonance imaging) and ultrasound to determine which they would rather undergo. Receives: Procedure: Patient preference between MRI and Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids
Arm 1 patients will undergo hysterectomy (per previously defined clinical decision unrelated to the study) 4-6 weeks after enrollment and imaging tests, allowing us to correlate imaging and pathologic findings
Measured: 1-2 months per patient
Secondary outcomes (1)
Patient preference between ultrasound and MRI
Patients will take a survey to assess their experiences and preferences for pelvic imaging tests within 6 months after having those tests
Measured: 6 months per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine BleedingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Association of University Radiologists, GE Radiology Research Academic Fellowship
- Responsible party
- Principal investigator, Katherine Maturen, M.D., University of Michigan
- Investigators
- Katherine Maturen, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992718
- Sponsor's protocol ID
- HUM00076620
- Status last verified
- May 2018
- First submitted
- 7 Nov 2013
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
- ClinicalTrials.gov ID
- NCT01992718
- Acronym / sponsor ID
- HUM00076620
- Conditions
- Uterine Bleeding, Uterine Fibroids, Adenomyosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Association of University Radiologists, GE Radiology Research Academic Fellowship
- Study start
- Nov 2013 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 25 Nov 2013 (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 improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging), ultrasound and ultrasound with elastography).
Detailed description
Currently benign conditions of the uterus are frequently underdiagnosed or misdiagnosed. This project will help determine which diagnostic radiology exams are most helpful to the clinician in providing accurate diagnosis. In addition, this study will evaluate which exam (MRI vs. Ultrasound) patients prefer over another exam.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evaluation of MRI, US for pelvic conditions | Active comparator | Procedure: Evaluation of MRI, US for pelvic and uterine conditionsMRI and ultrasound imaging will be used clinically to evaluate pelvic pain and abnormal uterine bleeding. The goal is to determine which exams are most helpful to the clinician in providing an accurate diagnosis as well as evaluating patient preference. |
| Patient preference MRI vs. US | Active comparator | Procedure: Patient preference between MRI and UltrasoundWe are asking subjects to evaluate patient preference between MRI (magnetic resonance imaging) and ultrasound to determine which they would rather undergo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Pelvic pain and/or abnormal uterine bleeding. (this is specific for Arm. 1 of this study)
- If you have had or are scheduled to have both a pelvic MRI (magnetic resonance imaging) and a pelvic ultrasound with 6 months of the time of enrollment. (this is specific to Arm 2 of this study).
- -
Key exclusion criteria (4 listed)
- If you are post-menopausal(have not had a period in at least one year's time).
- If you have been diagnosed with gynecological malignancy such as uterine, endometrial, cervical or ovarian cancer.
- If you are unable or unwilling to sign the informed consents
- If you are unable to undergo the research study exams -
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 |
|---|---|---|
| Evaluation of MRI, US for pelvic and uterine conditionsPelvic ultrasound with transabdominal and transvaginal imaging. The transvaginal ultrasound will include elastography (TVUS-E). Also, a pelvic MRI will be performed if not done in the last 6 months. The MRI is performed with IV gadolinium-based contrast (MultiHance ®). A patient survey will be included. | Procedure or surgery | Evaluation of MRI, US for pelvic conditions |
| Patient preference between MRI and UltrasoundSubjects may take part in this arm because they have recently had a MRI performed and scheduled for, or have recently undergone a pelvic ultrasound. Subjects will also be asked to complete a survey that will state their preference with regards to examination/imaging. This will be done over the phone and will take no longer than 30 minutes to complete. | Procedure or surgery | Patient preference MRI vs. US |
Primary outcome
Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids
Time frame: 1-2 months per patient
Arm 1 patients will undergo hysterectomy (per previously defined clinical decision unrelated to the study) 4-6 weeks after enrollment and imaging tests, allowing us to correlate imaging and pathologic findings
1 secondary outcome
Patient preference between ultrasound and MRI
Time frame: 6 months per patient
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 31 May 2018.
- Individual participant dataSharing planned: No
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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.
Katherine Maturen, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Evaluation of MRI, US for pelvic and uterine conditions and Patient preference between MRI and Ultrasound in people with Uterine Bleeding and Uterine Fibroids, run by University of Michigan 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 4 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 31 May 2018. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids (time frame: 1-2 months per patient). 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 31 May 2018.