MRI in Breast CancerMRINCT06707584
Role of MRI in Breast Cancer Subtypes
An observational study of MRI in Breast Cancer, run by Lamiaa Gomaa Ahmed Elsayed.
Trial summary
efficacy of MRI in detection of breast cancer molecular subtypes instead of biopsy and immunohistochemistry Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- MRI in Breast Cancer
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: any patient with breast cancer
Who may be able to join
- patients with breast cancer confirmed by histopathology,
Who cannot join
- breast implants
- general Contraindication of MRI as claustrophobia
About this study
Official title: Role of MRI in Detection of Breast Cancer Molecular Subtypes in Correlation With Immunohistochemistry Results
efficacy of MRI in detection of breast cancer molecular subtypes instead of biopsy and immunohistochemistry
Read the detailed description
2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): Patient with breast cancer (malignant breast mass) will do MRI breast and molecular subtypes will be assessed
MRI imaging studies will performed on a 1.5 T scanner , The patient is placed in the prone position with both breasts placed adequately in a double breast coil (four-channel phased array coil), MRI sequences are:
- Axial T1WI. 2. Axial T2WI. 3. Axial STIR. 4. DCE-MRI with post-processing subtraction images 5- Axial DWI at b value( 0, 400, 800 and 1000 mm^2 per second) and ADC map will performed 6. MRI spectroscopy MRI acquisition protocol MRI protocols includes
- Axial T2-weighted fast spin echo sequence: TR=3840 ms, TE=81 ms, slice thickness=3.5 mm, and matrix=448×448.
- Coronal T2-weighted fast spin echo sequence: TR=3840 ms, TE=81 ms, slice thickness=3.5 mm, and matrix=448×448.s
- Short tau inversion recovery - axial: TR=8540 ms, TE=59 ms, TI=170 ms, slice thickness=3.5 mm, and matrix=320×314.4.
- The standard dynamic protocol commenced with a coronal three-dimensional rapid Field echo (thrive) sense non-enhanced T1-weighted sequence.
- A gadolinium containing contrast was administered at a dose of 0.2 ml/ kg by power injection at a speed of 2.0 ml/s and flushed with 20 ml of saline solution at the same rate.
- Dynamic imaging was then done in five consecutive series at 90-s intervals. Standard subtraction images were obtained by subtracting precontract images from the early peak postcontrast image.
- Conditions
- MRI in Breast Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of MRI in breast cancer subtyping
To investigate the diagnostic accuracy of dynamic post contrast imaging MRI in evaluation of breast cancer molecular subtypes and DWI and ADC in detection of breast cancer molecular subtypes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Apr 2025 (estimated)
- Primary completion10 Aug 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRI in 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
- Other
- Time perspective
- Other
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lamiaa Gomaa Ahmed Elsayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lamiaa Gomaa Ahmed Elsayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707584
- Sponsor's protocol ID
- MRI in breast cancer types
- Acronym
- MRI
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of MRI in Detection of Breast Cancer Molecular Subtypes in Correlation With Immunohistochemistry Results
- ClinicalTrials.gov ID
- NCT06707584
- Acronym / sponsor ID
- MRI / MRI in breast cancer types
- Conditions
- MRI in Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Lamiaa Gomaa Ahmed ElsayedUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 10 Aug 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 27 Nov 2024 (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.
efficacy of MRI in detection of breast cancer molecular subtypes instead of biopsy and immunohistochemistry
Detailed description
2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): Patient with breast cancer (malignant breast mass) will do MRI breast and molecular subtypes will be assessed
MRI imaging studies will performed on a 1.5 T scanner , The patient is placed in the prone position with both breasts placed adequately in a double breast coil (four-channel phased array coil), MRI sequences are:
- Axial T1WI. 2. Axial T2WI. 3. Axial STIR. 4. DCE-MRI with post-processing subtraction images 5- Axial DWI at b value( 0, 400, 800 and 1000 mm^2 per second) and ADC map will performed 6. MRI spectroscopy MRI acquisition protocol MRI protocols includes
- Axial T2-weighted fast spin echo sequence: TR=3840 ms, TE=81 ms, slice thickness=3.5 mm, and matrix=448×448.
- Coronal T2-weighted fast spin echo sequence: TR=3840 ms, TE=81 ms, slice thickness=3.5 mm, and matrix=448×448.s
- Short tau inversion recovery - axial: TR=8540 ms, TE=59 ms, TI=170 ms, slice thickness=3.5 mm, and matrix=320×314.4.
- The standard dynamic protocol commenced with a coronal three-dimensional rapid Field echo (thrive) sense non-enhanced T1-weighted sequence.
- A gadolinium containing contrast was administered at a dose of 0.2 ml/ kg by power injection at a speed of 2.0 ml/s and flushed with 20 ml of saline solution at the same rate.
- Dynamic imaging was then done in five consecutive series at 90-s intervals. Standard subtraction images were obtained by subtracting precontract images from the early peak postcontrast image.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- any patient with breast cancer
Key inclusion criteria (1 listed)
- patients with breast cancer confirmed by histopathology,
Key exclusion criteria (2 listed)
- breast implants
- general Contraindication of MRI as claustrophobia
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
accuracy of MRI in breast cancer subtyping
Time frame: 5 years
To investigate the diagnostic accuracy of dynamic post contrast imaging MRI in evaluation of breast cancer molecular subtypes and DWI and ADC in detection of breast cancer molecular subtypes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Related trials for MRI in Breast Cancer
Not yet recruitingPhase 4
FES PET/MRI for Occult Disease in Lobular Breast Cancer
Lobular Breast Carcinoma
RecruitingPhase 1
A Study of 68Ga-FAPI Breast PET/MRI Scans in People With Breast Cancer
Breast Cancer, Invasive Breast Cancer
Not yet recruitingPhase 2
Adding Preoperative Radiotherapy Based on Early Treatment Response in Breast Cancer
Invasive Breast Cancer
Not yet recruitingPhase 1/2
MagSense® Human Epidermal Growth Factor Receptor 2 (HER2) Imaging Agent (MSH2IA)
HER2-positive Breast Cancer
Active, not recruiting
Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
Healthy Subject
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.
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 MRI in Breast Cancer, run by Lamiaa Gomaa Ahmed Elsayed.
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 2 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: opening soon, as of the sponsor's last update on 27 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
accuracy of MRI in breast cancer subtyping (time frame: 5 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 27 Nov 2024.