EndometriosisNCT04665414
Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
An observational study of Endometriosis and Adenomyosis, run by University Hospital Muenster at 1 site in Germany.
Trial summary
comparison of transvaginal ultrasound, transvaginal ultrasound elastography and MRI for the diagnosis of adenomyosis in patients receiving hysterectomy afterwards Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis, Adenomyosis
- What is being tested?
- MRI, transvaginal ultrasound and transvaginal ultrasound elastography
- How many people
- 103 participants
- Where
- 1 siteGermany
- Study dates
- 29 Sep 2017to 31 Jan 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients in accordance with eligibility criteria registered to receive hysterectomy because of a suspicion of adenomyosis according to the above criteria
Who may be able to join
- dysmenorrhea
- dyspareunia
- non cyclic lower abdominal pain
- hypermenorrhea
- menometrorrhaghia
- pain while compressing the Uterus during gyn exam
- Patient wants to participate
- Patient will receive hysterectomy
Who cannot join
- Patient declines to participate
- contraindications against MRI
- contraindications against ultrasound
- minor
- cannot give informed consent
- no hysterectomy planned
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Muenster
Münster, North Rhine-Westphalia, 48149
About this study
Official title: Value of Transvaginal Ultrasound, Transvaginal Sonographic Elastography and MRI for the Diagnosis of Adenomyosis
comparison of transvaginal ultrasound, transvaginal ultrasound elastography and MRI for the diagnosis of adenomyosis in patients receiving hysterectomy afterwards
- Conditions
- Endometriosis, Adenomyosis
- Being tested
- MRI, transvaginal ultrasound, transvaginal ultrasound elastography
- Keywords
- adenomyosis, endometriosis, MRI, elastography, ultrasound, hysterectomy
- Medical subject headings
- Endometriosis, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
preoperative MRI
transvaginal ultrasoundDiagnostic test
preoperative transvaginal ultrasound
transvaginal ultrasound elastographyDiagnostic test
preoperative transvaginal ultrasound elastography
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity MRI
sensitivity MRI
Measured: through study completion, an average of 1 year
specificity MRI
specificity MRI
Measured: through study completion, an average of 1 year
sensitivity transvaginal ultrasound
sensitivity transvaginal ultrasound
Measured: through study completion, an average of 1 year
specificity transvaginal ultrasound
specificity transvaginal ultrasound
Measured: through study completion, an average of 1 year
sensitivity transvaginal ultrasound elastography
sensitivity transvaginal ultrasound elastography
Measured: through study completion, an average of 1 year
specificity transvaginal ultrasound elastography
specificity transvaginal ultrasound elastography
Measured: through study completion, an average of 1 year
sensitivity intraoperative ENZIAN FA
sensitivity intraoperative ENZIAN FA
Measured: through study completion, an average of 1 year
specificity intraoperative ENZIAN FA
specificity intraoperative ENZIAN FA
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
sensitivity and specificity of single sonographic or MRI criteria or combinations thereof
sensitivity and specificity of single sonographic or MRI criteria or combinations thereof
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start29 Sep 2017
- Primary completion1 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster
- Investigators
- se D Schaefer, MD PhD, Principal investigator, University Hospital Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665414
- Sponsor's protocol ID
- Schäfer_Adenomyosis
- Status last verified
- Apr 2021
- First submitted
- 4 Dec 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be shared upon reasonable request according to regulations
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Transvaginal Ultrasound, Transvaginal Sonographic Elastography and MRI for the Diagnosis of Adenomyosis
- ClinicalTrials.gov ID
- NCT04665414
- Acronym / sponsor ID
- Schäfer_Adenomyosis
- Conditions
- Endometriosis, Adenomyosis
- Keywords
- adenomyosis, endometriosis, MRI, elastography, ultrasound, hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 11 Dec 2020 (actual)
- 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.
comparison of transvaginal ultrasound, transvaginal ultrasound elastography and MRI for the diagnosis of adenomyosis in patients receiving hysterectomy afterwards
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients in accordance with eligibility criteria registered to receive hysterectomy because of a suspicion of adenomyosis according to the above criteria
Key inclusion criteria (8 listed)
- dysmenorrhea
- dyspareunia
- non cyclic lower abdominal pain
- hypermenorrhea
- menometrorrhaghia
Key exclusion criteria (6 listed)
- Patient declines to participate
- contraindications against MRI
- contraindications against ultrasound
- minor
- cannot give informed consent
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 |
|---|---|---|
| MRIpreoperative MRI | Diagnostic test | – |
| transvaginal ultrasoundpreoperative transvaginal ultrasound | Diagnostic test | – |
| transvaginal ultrasound elastographypreoperative transvaginal ultrasound elastography | Diagnostic test | – |
Primary outcome
sensitivity MRI
Time frame: through study completion, an average of 1 year
sensitivity MRI
specificity MRI
Time frame: through study completion, an average of 1 year
specificity MRI
sensitivity transvaginal ultrasound
Time frame: through study completion, an average of 1 year
sensitivity transvaginal ultrasound
specificity transvaginal ultrasound
Time frame: through study completion, an average of 1 year
specificity transvaginal ultrasound
sensitivity transvaginal ultrasound elastography
Time frame: through study completion, an average of 1 year
sensitivity transvaginal ultrasound elastography
specificity transvaginal ultrasound elastography
Time frame: through study completion, an average of 1 year
specificity transvaginal ultrasound elastography
sensitivity intraoperative ENZIAN FA
Time frame: through study completion, an average of 1 year
sensitivity intraoperative ENZIAN FA
specificity intraoperative ENZIAN FA
Time frame: through study completion, an average of 1 year
specificity intraoperative ENZIAN FA
1 secondary outcome
sensitivity and specificity of single sonographic or MRI criteria or combinations thereof
Time frame: through study completion, an average of 1 year
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 28 Apr 2021.
- Individual participant dataSharing planned: Undecided. data will be shared upon reasonable request according to regulations
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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.
se D Schaefer, MD PhD principal investigator
University Hospital Muenster, Germany
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 Endometriosis and Adenomyosis, run by University Hospital Muenster at 1 site in Germany.
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 8 inclusion and 6 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 28 Apr 2021. 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 Germany. 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?
sensitivity MRI (time frame: through study completion, an average of 1 year). The study lists 8 primary outcomes in all. 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 28 Apr 2021.