Breast Cancer FemaleNCT03870659
Abbreviated Breast MRI in Cancer Detection
An observational study of Breast Cancer Female, run by Assiut University at 1 site in Egypt.
Trial summary
Breast cancer is one of the leading causes of death among women, with early detection being the key to improve prognosis and survival. Randomized controlled trials have found that screening mammography has decreased the mortality of breast cancer by 30%. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Breast MRI
- Type of treatment
- Surgery or procedure
- How many people
- 302 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 15 Mar 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women referred for performing breast MRI to exclude presence of breast cancer and their lesion characterization
Who may be able to join
- All women referred to our radiology department at assiut university hospital for performing breast MRI
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Value of Abbreviated Breast MRI in Cancer Detection
Breast cancer is one of the leading causes of death among women, with early detection being the key to improve prognosis and survival.
Randomized controlled trials have found that screening mammography has decreased the mortality of breast cancer by 30%.
Read more
However, with a sensitivity of 70%, mammography has its limitations particularly in women with dense breasts.
The use of breast MRI for screening has increased over the past decade. Most experiences exist in women at elevated familial risk of breast cancer. In these women, MRI screening shifts the stage distribution of breast cancers toward lower stages and reduces the fraction of interval cancers.
Kuhl et al in 2014 were the first to report on the feasibility of an abbreviated breast MRI protocol for breast cancer screening. Their protocol consisting of an unenhanced T1-weighted and first contrast-enhanced T1-weighted sequence, subtraction imaging, and a single MIP image.
This groundbreaking study found that image acquisition and interpretation time could be reduced without having a negative impact on diagnostic accuracy.
Read the detailed description
Breast MRI screening is associated with high direct and indirect costs. These, together with the lack of sites that offer high-level breast MRI, limit clinical access to screening MRIs.
One reason for the high cost is that current breast MRI protocols are time consuming to acquire and read. A typical MRI study occupies the MRI system for up to 40 minutes and generates several hundred images.
DCE-MRI allows the assessment of high-resolution breast morphology and enhancement kinetics to depict angiogenesis as a tumor-specific feature. At any given field strength, DCE-MRI is the most sensitive modality for breast cancer detection, with a pooled sensitivity of 93%; DCE-MRI has good pooled specificity of 71%.
With the abbreviated MRI protocol, the acquisition time was substantially decreased to 3 minutes, compared with 17 minutes for the full diagnostic protocol. The interpretation time of the abbreviated protocol was 28 seconds on average and 2.8 seconds when the MIP image alone was evaluated.
- Conditions
- Breast Cancer Female
- Being tested
- Breast MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast MRIRadiation
Magnetic resonance imaging to the breast
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate accuracy of abbreviated breast MRI in cancer detection
Sensitivity and specificity of abbreviated breast MRI in detection of cancer will be calculated and compared to those of the full protocol
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Apr 2019
- Primary completion30 Jun 2020
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AShassan, Assiut University
- Investigators
- Abeer, PhD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870659
- Sponsor's protocol ID
- Abbreviated Breast MRI
- Status last verified
- Jul 2023
- First submitted
- 8 Mar 2019
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Abbreviated Breast MRI in Cancer Detection
- ClinicalTrials.gov ID
- NCT03870659
- Acronym / sponsor ID
- Abbreviated Breast MRI
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 12 Mar 2019 (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.
Breast cancer is one of the leading causes of death among women, with early detection being the key to improve prognosis and survival.
Randomized controlled trials have found that screening mammography has decreased the mortality of breast cancer by 30%.
However, with a sensitivity of 70%, mammography has its limitations particularly in women with dense breasts.
The use of breast MRI for screening has increased over the past decade. Most experiences exist in women at elevated familial risk of breast cancer. In these women, MRI screening shifts the stage distribution of breast cancers toward lower stages and reduces the fraction of interval cancers.
Kuhl et al in 2014 were the first to report on the feasibility of an abbreviated breast MRI protocol for breast cancer screening. Their protocol consisting of an unenhanced T1-weighted and first contrast-enhanced T1-weighted sequence, subtraction imaging, and a single MIP image.
This groundbreaking study found that image acquisition and interpretation time could be reduced without having a negative impact on diagnostic accuracy.
Detailed description
Breast MRI screening is associated with high direct and indirect costs. These, together with the lack of sites that offer high-level breast MRI, limit clinical access to screening MRIs.
One reason for the high cost is that current breast MRI protocols are time consuming to acquire and read. A typical MRI study occupies the MRI system for up to 40 minutes and generates several hundred images.
DCE-MRI allows the assessment of high-resolution breast morphology and enhancement kinetics to depict angiogenesis as a tumor-specific feature. At any given field strength, DCE-MRI is the most sensitive modality for breast cancer detection, with a pooled sensitivity of 93%; DCE-MRI has good pooled specificity of 71%.
With the abbreviated MRI protocol, the acquisition time was substantially decreased to 3 minutes, compared with 17 minutes for the full diagnostic protocol. The interpretation time of the abbreviated protocol was 28 seconds on average and 2.8 seconds when the MIP image alone was evaluated.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women referred for performing breast MRI to exclude presence of breast cancer and their lesion characterization
Key inclusion criteria (1 listed)
- All women referred to our radiology department at assiut university hospital for performing breast MRI
Key exclusion criteria (1 listed)
- no exclusion criteria
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 |
|---|---|---|
| Breast MRIMagnetic resonance imaging to the breast | Radiation | – |
Primary outcome
To evaluate accuracy of abbreviated breast MRI in cancer detection
Time frame: 2 years
Sensitivity and specificity of abbreviated breast MRI in detection of cancer will be calculated and compared to those of the full protocol
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 19 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Abeer, PhD study director
Assiut University
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 Female, run by Assiut University at 1 site in Egypt.
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 19 Jul 2023. 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 Egypt. 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?
To evaluate accuracy of abbreviated breast MRI in cancer detection (time frame: 2 years). 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 19 Jul 2023.