Breast DiseasesCEDM&DBTVSMRNCT06089148
New Mammographic Techniques Versus MRI in Assessment of Breast Lesions
An observational study of Breast Diseases, run by Cairo University.
Trial summary
Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast lesions Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Diseases
- What is being tested?
- contrast enhanced digital mammography, tomosyntheis and MRI
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2016
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: FEMALE
Who may be able to join
- Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5 breast lesions.
- Clinical indication for MRI breast imaging.
- No histologically proven cancer before enrollment. Exclusion criteria
- 1. Pregnancy or possible pregnancy. 2. History of allergy to an iodinated contrast agent. 3. Renal impairment. 4. Contraindication for MRI examination
Who cannot join
None listed.
About this study
Official title: Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast Lesions
Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast lesions
Read the detailed description
Combined use of contrast-enhanced digital mammography (CEDM), and digital breast tomosynthesis (DBT), may be a reasonable alternative to MRI.
- Conditions
- Breast Diseases
- Being tested
- contrast enhanced digital mammography, tomosyntheis and MRI
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast enhanced digital mammography, tomosyntheis and MRIDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| contrast enhanced mammography, tomosynthesis and MRI | CEDM and tomosynthesis versus MRI Receives: Diagnostic Test: contrast enhanced digital mammography, tomosyntheis and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity, specificity of'tomosynthesis and contrast enhanced mammography and MRI breast are measured in assessment of breast lesions and their pre-operative assessment of breast cancer
diagnostic
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study startJun 2015
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo 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 only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa A Haggag, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089148
- Sponsor's protocol ID
- 141014
- Acronym
- CEDM&DBTVSMR
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast Lesions
- ClinicalTrials.gov ID
- NCT06089148
- Acronym / sponsor ID
- CEDM&DBTVSMR / 141014
- Conditions
- Breast Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Oct 2023 (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.
Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast lesions
Detailed description
Combined use of contrast-enhanced digital mammography (CEDM), and digital breast tomosynthesis (DBT), may be a reasonable alternative to MRI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| contrast enhanced mammography, tomosynthesis and MRI | – | Diagnostic Test: contrast enhanced digital mammography, tomosyntheis and MRICEDM and tomosynthesis versus MRI |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- FEMALE
Key inclusion criteria (4 listed)
- Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5 breast lesions.
- Clinical indication for MRI breast imaging.
- No histologically proven cancer before enrollment. Exclusion criteria
- 1. Pregnancy or possible pregnancy. 2. History of allergy to an iodinated contrast agent. 3. Renal impairment. 4. Contraindication for MRI examination
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| contrast enhanced digital mammography, tomosyntheis and MRI | Diagnostic test | contrast enhanced mammography, tomosynthesis and MRI |
Primary outcome
sensitivity, specificity of'tomosynthesis and contrast enhanced mammography and MRI breast are measured in assessment of breast lesions and their pre-operative assessment of breast cancer
Time frame: 1year
diagnostic
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 18 Oct 2023.
- Individual participant dataSharing planned: Yes. study protocol
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Diseases, run by Cairo 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 4 inclusion and 0 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 18 Oct 2023. 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?
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?
sensitivity, specificity of'tomosynthesis and contrast enhanced mammography and MRI breast are measured in assessment of breast lesions and their pre-operative assessment of breast cancer (time frame: 1year). 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 18 Oct 2023.