Breast DiseasesNCT03088436
Feasibility Study of Supine Breast MRI : Comparison With Prone MRI and Comfort Assessment
An observational study of Breast Diseases, run by Institut de Cancérologie de Lorraine.
Trial summary
The aim of the present study was to determine the prone-to-supine displacement of breast lesions using preoperative prone MRI and supine second-look ultrasound data Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Diseases
- What is being tested?
- preoperative prone MRI and supine second-look ultrasound data
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 15 Jan 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients records were extracted from the electronic health record system of Institut de Cancérologie de Lorraine
Who may be able to join
- The inclusion criteria were being a woman with breast lesions whose assessment involved breast MRI and ultrasound at our institution. There were no exclusion criteria.
Who cannot join
- -
About this study
The aim of the present study was to determine the prone-to-supine displacement of breast lesions using preoperative prone MRI and supine second-look ultrasound data
- Conditions
- Breast Diseases
- Being tested
- preoperative prone MRI and supine second-look ultrasound data
- Keywords
- MRI, Breast
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative prone MRI and supine second-look ultrasound dataDevice
Patients were examined using a standard clinical MRI protocol in the prone position with both arms placed above the head. Second-look ultrasonographies were performed. Patients were instructed to lie supine, with their hands behind their heads.
What is being measured
The primary outcome is the main question the study is designed to answer.
distance to the nipple (mm)
the distance to the nipple for lesion was determined using prone MRI and supine ultrasound
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Jan 2014
- Primary completion15 Jan 2015
- Study completion15 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088436
- Sponsor's protocol ID
- ICL_2014_0003
- Status last verified
- Mar 2017
- First submitted
- 17 Mar 2017
- Last updated
- 23 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Supine Breast MRI : Comparison With Prone MRI and Comfort Assessment
- ClinicalTrials.gov ID
- NCT03088436
- Acronym / sponsor ID
- ICL_2014_0003
- Conditions
- Breast Diseases
- Keywords
- MRI, Breast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 15 Jan 2015 (actual)
- Study completion
- 15 Jan 2015 (actual)
- First posted
- 23 Mar 2017 (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.
The aim of the present study was to determine the prone-to-supine displacement of breast lesions using preoperative prone MRI and supine second-look ultrasound data
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients records were extracted from the electronic health record system of Institut de Cancérologie de Lorraine
Key inclusion criteria (1 listed)
- The inclusion criteria were being a woman with breast lesions whose assessment involved breast MRI and ultrasound at our institution. There were no exclusion criteria.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| preoperative prone MRI and supine second-look ultrasound dataPatients were examined using a standard clinical MRI protocol in the prone position with both arms placed above the head. Second-look ultrasonographies were performed. Patients were instructed to lie supine, with their hands behind their heads. | Device | – |
Primary outcome
distance to the nipple (mm)
Time frame: 1 day
the distance to the nipple for lesion was determined using prone MRI and supine ultrasound
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 23 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Diseases, run by Institut de Cancérologie de Lorraine.
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 1 inclusion and 1 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
distance to the nipple (mm) (time frame: 1 day). 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 23 Mar 2017.