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Mammographic DensityNCT03696147

Diffusion Magnetic Resonance Imaging in Mamographically Detected Asymmetric Densities

An observational study of Mammographic Density, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the study is to identify the role of diffusion weighted MRI in the assessment of the clinical significance and outcomes of asymmetric breast densities identified on mammograms, and to identify the inconclusive mammographic findings most frequently associated with occult breast carcinoma. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Mammographic Density
What is being tested?
Magnetic resonance imaging
Type of treatment
Medical device
How many people
50 participants
Where
No sites listed yet
Study dates
1 Dec 2018to Oct 2019
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 20 to 80 years
  • All sexes
  • Adult, Older adult

Study population: sample size was calculated using EpiInfo7statcalc. Prog. With the following input population size: 120 expected frequency: 6% confidence limits: 5% design effect: 1.0 clusters: 1 The sample size was 50 cases at 95%confidence level.

Who may be able to join

  • All patients presented with asymmetric breast densities, seen on screening or diagnostic mammograms.

Who cannot join

  • Patients with cardiac pacemakers.
  • Patients with brain aneurysm clips.
  • Patients with cochlear implants.
  • Patients with vascular stents.
  • Claustrophobic.

Trial locations and contacts

No sites are listed yet.

Shimaa Ali Saad, Master contact

+201022669516

drshima15@gmail.com

Eman Abo Elhamd Ahmad, MD contact

+20100198073

dr.eman_08@yahoo.com

About this study

Official title: Role of Diffusion Magnetic Resonance Imaging in Assessment of Mammographically Detected Asymmetric Densities

The aim of the study is to identify the role of diffusion weighted MRI in the assessment of the clinical significance and outcomes of asymmetric breast densities identified on mammograms, and to identify the inconclusive mammographic findings most frequently associated with occult breast carcinoma.

Read the detailed description

Although there is clearly a wide variation in breast size and parenchymal pattern, the breasts are generally symmetric structures with similar density and architecture. However, asymmetric breast tissue is encountered relatively frequently.

Asymmetric breast tissue is usually benign and secondary to variations in normal breast tissue, postoperative change from a previous biopsy, hormone replacement therapy , or merely poor positioning. However, an asymmetric area may indicate a developing mass or an underlying cancer.

The American College of Radiology (ACR), Breast Imaging Reporting and Data System (BI-RADS) defined four different types of asymmetric breast findings:

  1. Asymmetric Breast tissue: refers to a greater volume or density of breast tissue in one breast than in the corresponding area in the contra lateral breast.
  2. Densities seen in one projection: reflect a density seen in only one mammographic projection.
  3. Architectural distortion: refers to a focal area of breast tissue that appears distorted with no definable central mass. Speculations radiate from a common point, and there is an area of focal retraction and tethering of normal parenchyma.
  4. Focal asymmetric densities: refer to focal asymmetric densities that are seen on two mammographic views but cannot be accurately identified as a true mass.

These lesions are frequently encountered at screening and diagnostic mammography and are significant because they may indicate a neoplasm, especially if an associated palpable mass is present. Once these lesions are detected at standard mammography, supplementary breast imaging with additional mammographic views and ultrasonography (US) can be a key aspect of work-up.

However, these techniques may be insufficient to make a final BI-RADS assessment and may have limited sensitivity and specificity for the detection and diagnosis of breast lesions, yielding equivocal results. Certainty of the presence or absence of a true lesion can be difficult, and the findings remain inconclusive. Moreover, Architectural distortion should always be regarded with suspicion but differentiation from summation artifact is problematic. Developing asymmetric densities need to be evaluated unless they can be explained in terms of benign causes.

In these situations, MRI can be performed as an additional problem- solving procedure. Positive MRI examination will prompt biopsy and allow for the timely detection of malignancies that may otherwise would gone undiagnosed, while a negative MRI will allow increased confidence that the equivocal finding was likely caused by summation artifact or benign tissue , so follow-up surveillance mammography without biopsy will be undergone.

Although conventional breast MRI has a high sensitivity (89-100%) in the characterization of breast lesions . However, an overlap between benign and malignant findings still persists, resulting in a variable specificity (50-90%).

The DWI derives images from the difference of water molecules motion (Brownian motion) in tissues, resulting in quantitative and qualitative data reflecting changes at the cellular level and, consequently, unique information on the tumor cellularity and cell membranes integrity. This would allow the increase in breast MRI specificity and reduction of false-positive results and unnecessary biopsies.

Cell density might play an important role in the different ADCs obtained from benign and malignant breast lesions and the measurement of extracellular water content may be an additional feature that can improve MRI specificity.

The main objectives in using diffusion sequences are to optimize characterization of lesions differentiating benign from malignant tumors; and to improve detection of small lesions, which requires an optimal signal-to-noise ratio. several authors have shown that this technique is relevant for smaller masses (5 mm) and even for non-mass like enhancements.

Being tested
Magnetic resonance imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic resonance imagingDevice

    Diffusion weighted sequence of MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of diffusion MRI finding with the pathology of the specimens

    Analysis of diffusion weighted images and ADC values to defferntiate different pathologies causing asymmetric densities in routine screening or diagnostic mammography

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2018
  2. Study start1 Dec 2018 (estimated)
  3. Primary completionJul 2019 (estimated)
  4. Study completionOct 2019 (estimated)

Resources

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
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03696147
Sponsor's protocol ID
DWI breast cancer
Status last verified
Oct 2018
First submitted
3 Oct 2018
Last updated
30 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mammographic Density, run by Assiut University.

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 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: status not confirmed, as of the sponsor's last update on 30 Oct 2018. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shimaa Ali Saad, Master (+201022669516, drshima15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of diffusion MRI finding with the pathology of the specimens (time frame: Baseline). 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 30 Oct 2018.

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