Breast CancerNCT04914494
Cancer Predictive Score on Breast MRI
An observational study of Breast Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Sometimes, breast ultrasound and mammographic can't be diagnose suspsious lesions ( no substratum). So a MRI-guided breast biopsy is perfomed and disclosed ultimately benign lesions. The aim of this retrospective study is to establish a predictive MRI score of occult breast lesions by mammography and ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 428 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 30 Sep 2022
- 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: Women aged 18 to 50 years old
Who may be able to join
- women aged 18 and more
- performed MRI-guided breast biopsy
Who cannot join
- Not MRI-guided breast biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Malignity Predictive Factors on Breast MRI With Ultrasound and Mammography Occult Lesions
Sometimes, breast ultrasound and mammographic can't be diagnose suspsious lesions ( no substratum). So a MRI-guided breast biopsy is perfomed and disclosed ultimately benign lesions.
The aim of this retrospective study is to establish a predictive MRI score of occult breast lesions by mammography and ultrasound.
- Conditions
- Breast Cancer
- Keywords
- Women imaging, Diagnostic Imaging, Magnetic Resonance Imaging, Breast biopsy, Breast cancer detection, predictive factors, Radiology, Breast lesion diagnosis
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with MRI characteristics of breast lesions
MRI characteristics of breast lesions :
shape, contours, size, enhancement, perileeal edema, enhancement curve
Measured: 1 day
Secondary outcomes (1)
predictive score for the benignity of lesions seen on MRI
predictive score for the benignity of lesions seen on MRI (and not on mammography and ultrasound) with the criteria which will emerge after multivariate analysis and which will be weighted .
score out of 10, with 3 to 5 criteria rated from 0 to 2. 10 would be in favor of benignity and 0 in favor of malignancy.
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 posted4 Jun 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2021
- Study completion30 Sep 2022 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice TAOUREL, MD.PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914494
- Sponsor's protocol ID
- RECHMPL21_0379
- Status last verified
- Jan 2022
- First submitted
- 2 Jun 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malignity Predictive Factors on Breast MRI With Ultrasound and Mammography Occult Lesions
- ClinicalTrials.gov ID
- NCT04914494
- Acronym / sponsor ID
- RECHMPL21_0379
- Conditions
- Breast Cancer
- Keywords
- Women imaging, Diagnostic Imaging, Magnetic Resonance Imaging, Breast biopsy, Breast cancer detection, predictive factors, Radiology, Breast lesion diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 4 Jun 2021 (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.
Sometimes, breast ultrasound and mammographic can't be diagnose suspsious lesions ( no substratum). So a MRI-guided breast biopsy is perfomed and disclosed ultimately benign lesions.
The aim of this retrospective study is to establish a predictive MRI score of occult breast lesions by mammography and ultrasound.
Study design
- Observational model
- Cohort
- 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
- Women aged 18 to 50 years old
Key inclusion criteria (2 listed)
- women aged 18 and more
- performed MRI-guided breast biopsy
Key exclusion criteria (1 listed)
- Not MRI-guided breast biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with MRI characteristics of breast lesions
Time frame: 1 day
MRI characteristics of breast lesions : shape, contours, size, enhancement, perileeal edema, enhancement curve
1 secondary outcome
predictive score for the benignity of lesions seen on MRI
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Patrice TAOUREL, MD.PhD principal investigator
University Hospital, Montpellier
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 Breast Cancer, run by University Hospital, Montpellier 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 2 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: status not confirmed, as of the sponsor's last update on 26 Jan 2022. 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?
Results are not available in the source record.
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?
Number of participants with MRI characteristics of breast lesions (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 26 Jan 2022.