Role of MRI in Evaluation of Breast CancerNCT05301790
Breast MRI in Evaluation of Pathologic Response in Patients With Breast Cancer With Neoadjuvent Chemotherapy
An observational study of Role of MRI in Evaluation of Breast Cancer, run by Assiut University.
Trial summary
evaluation of pathological response in breast mass by use of breast MRI in patients receiving neoadjuvent chemotherapy via comparison with pathological results Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Role of MRI in Evaluation of Breast Cancer
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Dec 2024
- 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 to 80 years
- Women only
- Adult, Older adult
Study population: * all women referred to the radiology department for breast MRI examination either for screening, evaluation of suspicious lesions onsono-mammography \ * Patients with locally advanced breast cancer * Patients with early stage breast cancer and chemo-responsive tumour markers (i.e. triple negative, Her2+), who will benefit from downsizing for breast conserving surgery (BCS) * Absolute or Relative contraindications to surgery (advanced age/multiple medical comorbidities) in the setting of estrogen receptor positive tumours (for consideration of neoadjuvant endocrine therapy)3 * Patients must be elder than 18 years old. * patients with accepted renal function
Who may be able to join
- all women referred to the radiology department for breast MRI examination either for screening, evaluation of suspicious lesions onsono-mammography \
- Patients with locally advanced breast cancer
- Patients with early stage breast cancer and chemo-responsive tumour markers (i.e. triple negative, Her2+), who will benefit from downsizing for breast conserving surgery (BCS)
- Absolute or Relative contraindications to surgery (advanced age/multiple medical comorbidities) in the setting of estrogen receptor positive tumours (for consideration of neoadjuvant endocrine therapy)3
- Patients must be elder than 18 years old.
- patients with accepted renal function
Who cannot join
- Patients with metastatic breast cancer.
- Patient with breast mass more than 5 cm .
- Patients with fungating breast mass .
- Patients with stage IV [tumor spread to chest wall and to skin ].
- pregnant women especially in 1th trimester.
- Patient with presence of any paramagnetic substance as pacemakers.
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- severely ill patients .
- patients with claustrophobia.
- arrhythmic patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Added Value of Breast MRI in Evaluation of Pathologic Response in Patients With Locally Advanced Breast Cancer Who Undergo Neoadjuvent Chemotherapy
evaluation of pathological response in breast mass by use of breast MRI in patients receiving neoadjuvent chemotherapy via comparison with pathological results
Read the detailed description
evaluation of pathological response in locally advanced breast masses by use of breast MRI in patients receiving neoadjuvent chemotherapy via comparison with pathological results
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
use of MRI modality of imaging in evaluation of pathologic response in patients with breast cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of MRI findings with pathologic results
added value of breast MRI in evaluation of pathologic response in patients with locally advanced breast cancer who undergo neoadjvent chemotherapy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startMay 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Role of MRI in Evaluation of Breast CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Maher Ebied Maher, Assiut University
- Investigators
- lamiaa mohamed refaat, assisstant professor, Study director, assiut university -south egypt cancer instituteomar mostafa, lecturer, Study director, assiut university-south egypt cancer institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301790
- Sponsor's protocol ID
- MRI in breast cancer
- Status last verified
- Mar 2022
- First submitted
- 20 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of Breast MRI in Evaluation of Pathologic Response in Patients With Locally Advanced Breast Cancer Who Undergo Neoadjuvent Chemotherapy
- ClinicalTrials.gov ID
- NCT05301790
- Acronym / sponsor ID
- MRI in breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Mar 2022 (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.
evaluation of pathological response in breast mass by use of breast MRI in patients receiving neoadjuvent chemotherapy via comparison with pathological results
Detailed description
evaluation of pathological response in locally advanced breast masses by use of breast MRI in patients receiving neoadjuvent chemotherapy via comparison with pathological results
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- * all women referred to the radiology department for breast MRI examination either for screening, evaluation of suspicious lesions onsono-mammography \ * Patients with locally advanced breast cancer * Patients with early stage breast cancer and chemo-responsive tumour markers (i.e. triple negative, Her2+), who will benefit from downsizing for breast conserving surgery (BCS) * Absolute or Relative contraindications to surgery (advanced age/multiple medical comorbidities) in the setting of estrogen receptor positive tumours (for consideration of neoadjuvant endocrine therapy)3 * Patients must be elder than 18 years old. * patients with accepted renal function
Key inclusion criteria (6 listed)
- all women referred to the radiology department for breast MRI examination either for screening, evaluation of suspicious lesions onsono-mammography \
- patients with accepted renal function
Key exclusion criteria (9 listed)
- Patients with metastatic breast cancer.
- Patient with breast mass more than 5 cm .
- Patients with fungating breast mass .
- Patients with stage IV [tumor spread to chest wall and to skin ].
- pregnant women especially in 1th trimester.
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 |
|---|---|---|
| MRIuse of MRI modality of imaging in evaluation of pathologic response in patients with breast cancer | Device | – |
Primary outcome
comparison of MRI findings with pathologic results
Time frame: baseline
added value of breast MRI in evaluation of pathologic response in patients with locally advanced breast cancer who undergo neoadjvent chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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.
lamiaa mohamed refaat, assisstant professor study director
assiut university -south egypt cancer institute
omar mostafa, lecturer study director
assiut university-south egypt cancer institute
Questions about this trial
What is this clinical trial studying?
An observational study of Role of MRI in Evaluation of Breast Cancer, 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 6 inclusion and 9 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 31 Mar 2022. 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 Doaa Maher, resident (01050147500, dm953407@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of MRI findings with pathologic results (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 31 Mar 2022.