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

March 20, 2022 updated by: Doaa Maher Ebied Maher, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: lamiaa mohamed refaat, assisstant professor, Assiut university -south egypt cancer institute
  • Study Director: omar mostafa, lecturer, assiut university-south egypt cancer institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

March 20, 2022

First Submitted That Met QC Criteria

March 20, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 20, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRI in breast cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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