Clinical trial NCT05301790: Breast MRI in Evaluation of Pathologic Response in Patients With Breast Cancer With Neoadjuvent Chemotherapy
Official title: Added Value of Breast MRI in Evaluation of Pathologic Response in Patients With Locally Advanced Breast Cancer Who Undergo Neoadjuvent Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Role of MRI in Evaluation of Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* severely ill patients .
* patients with claustrophobia.
* arrhythmic patients

Primary outcomes:
measure: comparison of MRI findings with pathologic results
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: assiut university -south egypt cancer institute
name: lamiaa mohamed refaat, assisstant professor
role: STUDY_DIRECTOR
affiliation: assiut university-south egypt cancer institute
name: omar mostafa, lecturer
role: STUDY_DIRECTOR
References: