Breast CancerEFIMEDNCT02865239
Feasibility Study of Breast MRI in Decubitus Position
A study testing Position for the 3.0 Tesla in Magnetic Resonance Imaging in people with Breast Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
Breast MRI is performed in prone position which causes a number of questions. Indeed, the correlation with mammography and echography and the identification of preoperative lesions can be complex as echography and surgery are carried in supine position while mammography is performed in standing position. Read more about this study
- Who is it for?
- Ages Up to 18 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Position for the 3.0 Tesla in Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2015to 20 Aug 2015
- 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 Up to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient to benefit a MRI in the assessment for a breast carcinoma or a suspicious of breast carcinoma
- Assessment on 3.0 Tesla in Magnetic Resonance Imaging
- Age >18 years old
- ECOG performance status ≤ 3
- Ability to provide written informed consent form
Who cannot join
- Age < 18 years old
- Claustrophobia
- Contraindication to the injection of contrast medium Gadoline
- Contraindication to MRI
- Persons deprived of liberty or under supervision
Trial locations and contacts
1 site in 1 country.
About this study
Breast MRI is performed in prone position which causes a number of questions. Indeed, the correlation with mammography and echography and the identification of preoperative lesions can be complex as echography and surgery are carried in supine position while mammography is performed in standing position.
Moreover, the prone position is often considered as uncomfortable by the patients. However, there is few publications in the literature on breast MRI in decubitus position.
- Conditions
- Breast Cancer
- Being tested
- Position for the 3.0 Tesla in Magnetic Resonance Imaging
- Keywords
- Imaging, Three-Dimensional, Magnetic Resonance Imaging/methods*, Breast Neoplasms/diagnosis*, Prone Position, Prospective Studies
- Medical subject headings
- Breast Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position for the 3.0 Tesla in Magnetic Resonance ImagingProcedure or surgery
Eligible patients will have a standard MRI in prone position. At the end of this examination, all patients will have an other standard MRI in supine position.
This examination is then extended by 10 minutes without additional injection of contrast medium
| Study group | Role | What they receive |
|---|---|---|
| Supine position | Placebo comparator | 3.0 tesla MRI in supine position Receives: Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging |
| Prone position | Active comparator | 3.0 tesla MRI in prone position Receives: Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of lesions where the topography is discordant between the positions (prone and supine).
The topography is considered discordant if the location of the lesion is different between prone and supine positions (location will be described as the positions on a clock) and / or the distance from the nipple to the lesion is greater than 2cm between prone and supine positions.
Measured: 1 day
Secondary outcomes (5)
Comfort patient in supine position compared to the prone position using a self-administered questionnaire
Measured: 1 day
distance from the anterior border of the lesion to the nipple in supine position compared to the prone position
Measured: 1 day
distance from cutaneous projection of the lesion to the nipple in supine position compared to the prone position
Measured: 1 day
distance from lesion to pectoralis major muscle in supine position compared to the prone position
Measured: 1 day
Quandrant of the lesions and positions on a clock in supine position compared to the prone position
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 posted12 Aug 2016 (estimated)
- Study start25 Jun 2015
- Primary completion20 Aug 2015
- Study completion20 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- OLDRINI GUILLAUME, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865239
- Sponsor's protocol ID
- 2015-A00578-41
- Acronym
- EFIMED
- Status last verified
- Aug 2018
- First submitted
- 5 Jul 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Breast MRI in Decubitus Position
- ClinicalTrials.gov ID
- NCT02865239
- Acronym / sponsor ID
- EFIMED / 2015-A00578-41
- Conditions
- Breast Cancer
- Keywords
- Imaging, Three-Dimensional, Magnetic Resonance Imaging/methods*, Breast Neoplasms/diagnosis*, Prone Position, Prospective Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 25 Jun 2015 (actual)
- Primary completion
- 20 Aug 2015 (actual)
- Study completion
- 20 Aug 2015 (actual)
- First posted
- 12 Aug 2016 (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.
Breast MRI is performed in prone position which causes a number of questions. Indeed, the correlation with mammography and echography and the identification of preoperative lesions can be complex as echography and surgery are carried in supine position while mammography is performed in standing position.
Moreover, the prone position is often considered as uncomfortable by the patients. However, there is few publications in the literature on breast MRI in decubitus position.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine position | Placebo comparator | Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging3.0 tesla MRI in supine position |
| Prone position | Active comparator | Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging3.0 tesla MRI in prone position |
Who may qualify
- Ages
- Up to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patient to benefit a MRI in the assessment for a breast carcinoma or a suspicious of breast carcinoma
- Assessment on 3.0 Tesla in Magnetic Resonance Imaging
- Age >18 years old
- ECOG performance status ≤ 3
- Ability to provide written informed consent form
Key exclusion criteria (5 listed)
- Age < 18 years old
- Claustrophobia
- Contraindication to the injection of contrast medium Gadoline
- Contraindication to MRI
- Persons deprived of liberty or under supervision
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 |
|---|---|---|
| Position for the 3.0 Tesla in Magnetic Resonance ImagingEligible patients will have a standard MRI in prone position. At the end of this examination, all patients will have an other standard MRI in supine position. This examination is then extended by 10 minutes without additional injection of contrast medium | Procedure or surgery | Prone position, Supine position |
Primary outcome
Percentage of lesions where the topography is discordant between the positions (prone and supine).
Time frame: 1 day
The topography is considered discordant if the location of the lesion is different between prone and supine positions (location will be described as the positions on a clock) and / or the distance from the nipple to the lesion is greater than 2cm between prone and supine positions.
5 secondary outcomes
Comfort patient in supine position compared to the prone position using a self-administered questionnaire
Time frame: 1 day
distance from the anterior border of the lesion to the nipple in supine position compared to the prone position
Time frame: 1 day
distance from cutaneous projection of the lesion to the nipple in supine position compared to the prone position
Time frame: 1 day
distance from lesion to pectoralis major muscle in supine position compared to the prone position
Time frame: 1 day
Quandrant of the lesions and positions on a clock in supine position compared to the prone position
Time frame: 1 day
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 8 Aug 2018.
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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.
OLDRINI GUILLAUME, MD principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Position for the 3.0 Tesla in Magnetic Resonance Imaging in people with Breast Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
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 5 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 8 Aug 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 France. 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. Some participants in this study may receive a placebo. 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?
Percentage of lesions where the topography is discordant between the positions (prone and supine). (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 8 Aug 2018.