Breast MRI in Evaluation of Pathologic Response in Patients With Breast Cancer With Neoadjuvent Chemotherapy

NCT05301790 | Unknown

• 1 other identifier: MRI in breast cancer
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

evaluation of pathological response in breast mass by use of breast MRI in patients receiving neoadjuvent chemotherapy via comparison with pathological results

Conditions

Role of MRI in Evaluation of Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  baseline

Interventions

MRI DEVICE

use of MRI modality of imaging in evaluation of pathologic response in patients with breast cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Officials

• lamiaa mohamed refaat, assisstant professor

  assiut university -south egypt cancer institute

  STUDY DIRECTOR

• omar mostafa, lecturer

  assiut university-south egypt cancer institute

  STUDY DIRECTOR

Central Study Contacts

Doaa Maher, resident

CONTACT

01050147500; dm953407@gmail.com

hasan megally, professor

CONTACT

01006209584; hasanibrahim48@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: March 31, 2022
• Study Start: May 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share