Breast CancerCOMPRIMNCT02826369
Use of Compressed Sensing in Breast MRI
A study testing 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 increasingly important in breast screening imaging. It is currently based on dynamic sequences after contrast injection whose temporal resolution must be less than 90 seconds with dynamic acquisitions at different times. These curves profiles are designed to differentiate benign from malignant lesions. 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?
- 3.0 Tesla in Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2016to 12 Apr 2016
- 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
- Age >18 years old
- Assessment on 3.0 Tesla in Magnetic Resonance Imaging
- ECOG performance status ≤ 3
- Ability to provide an informed written consent form
Who cannot join
- Age < 18 years old
- Claustrophobia
- Contraindication to the injection of gadolinium contrast medium
- 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 increasingly important in breast screening imaging. It is currently based on dynamic sequences after contrast injection whose temporal resolution must be less than 90 seconds with dynamic acquisitions at different times.
These curves profiles are designed to differentiate benign from malignant lesions. Recently, Mann et al, (2014) showed that increasing the temporal resolution of dynamic acquisitions; lesion enhancement curves over time were more accurate than the curves usually performed.
It seems necessary to work on sequences having better temporal resolution without compromising however spatial resolution.
- Conditions
- Breast Cancer
- Being tested
- 3.0 Tesla in Magnetic Resonance Imaging
- Keywords
- Algorithms, Image Processing, Computer-Assisted/methods*, Magnetic Resonance Imaging/methods*, Data Compression, Breast Neoplasms
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3.0 Tesla in Magnetic Resonance ImagingOther
Eligible patient will have a standard MRI. The images taken before 4min30 and after 6min after to the injection of gadolimium contrast medium will be carried out with the standard image acquisition.
The images taken between 4min30 and 6min after the injection of gadolimium contrast medium will be carried out with the compressed sensing image acquisition.
| Study group | Role | What they receive |
|---|---|---|
| 3.0 Tesla in Magnetic Resonance Imaging | Experimental | Not described Receives: Other: 3.0 Tesla in Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between compressed sensing and standard image acquisition
Agreement between compressed sensing and standard image acquisition is defined by percentage of lesions detected by both modes of acquisitions
Measured: 1 day
Secondary outcomes (2)
Analysis of dammage contours
Analysis of lesions contours will be performed according to Bi-RADS classification
Measured: 1 day
Image quality in compressed sensing acquisition
The image quality will be evaluated using a quality scale
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 posted11 Jul 2016 (estimated)
- Study start29 Mar 2016
- Primary completion12 Apr 2016
- Study completion12 Apr 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 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
- NCT02826369
- Sponsor's protocol ID
- 2015-A00581-48
- Acronym
- COMPRIM
- Status last verified
- Aug 2018
- First submitted
- 5 Jul 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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
- Use of Compressed Sensing in Breast MRI
- ClinicalTrials.gov ID
- NCT02826369
- Acronym / sponsor ID
- COMPRIM / 2015-A00581-48
- Conditions
- Breast Cancer
- Keywords
- Algorithms, Image Processing, Computer-Assisted/methods*, Magnetic Resonance Imaging/methods*, Data Compression, Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 12 Apr 2016 (actual)
- Study completion
- 12 Apr 2016 (actual)
- First posted
- 11 Jul 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 increasingly important in breast screening imaging. It is currently based on dynamic sequences after contrast injection whose temporal resolution must be less than 90 seconds with dynamic acquisitions at different times.
These curves profiles are designed to differentiate benign from malignant lesions. Recently, Mann et al, (2014) showed that increasing the temporal resolution of dynamic acquisitions; lesion enhancement curves over time were more accurate than the curves usually performed.
It seems necessary to work on sequences having better temporal resolution without compromising however spatial resolution.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3.0 Tesla in Magnetic Resonance Imaging | Experimental | Other: 3.0 Tesla in Magnetic Resonance Imaging |
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
- Age >18 years old
- Assessment on 3.0 Tesla in Magnetic Resonance Imaging
- ECOG performance status ≤ 3
- Ability to provide an informed written consent form
Key exclusion criteria (5 listed)
- Age < 18 years old
- Claustrophobia
- Contraindication to the injection of gadolinium contrast medium
- 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 |
|---|---|---|
| 3.0 Tesla in Magnetic Resonance ImagingEligible patient will have a standard MRI. The images taken before 4min30 and after 6min after to the injection of gadolimium contrast medium will be carried out with the standard image acquisition. The images taken between 4min30 and 6min after the injection of gadolimium contrast medium will be carried out with the compressed sensing image acquisition. | Other | 3.0 Tesla in Magnetic Resonance Imaging |
Primary outcome
Agreement between compressed sensing and standard image acquisition
Time frame: 1 day
Agreement between compressed sensing and standard image acquisition is defined by percentage of lesions detected by both modes of acquisitions
2 secondary outcomes
Analysis of dammage contours
Time frame: 1 day
Image quality in compressed sensing acquisition
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.
- 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.
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 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. 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?
Agreement between compressed sensing and standard image acquisition (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.