Accuracy Of Contrast Enhanced Mamography in Predicting Response of Breast Cancer Post Neoadjuvant Chemotherapy

November 19, 2021 updated by: DMAhmed, Assiut University

Contrast Enhanced Mamography in Predicting Response of Breast Cancer Post Neoadjuvant Chemotherapy

The aim of this work to evaluate the accuracy of contrast enhanced spectral mamography in predicting the response to NAC and assessment of residual disease in breast cancer patients

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This a prospective series ,will be performed for 50 patients diagnosed by biopsy as breast cancer who will be scheduled for surgery after completing the full coarse of neoadjuvant chemotherapy

Study Type

Observational

Enrollment (Anticipated)

50

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

50 patients who will attend to outpatient surgical and oncology clinicS of Assiut university and diagnosed by biopsy as breast cancer

Description

Inclusion Criteria:

  • patient confirmed diagnosed by early breast cancer decided to received neoadjuvant treatment
  • locally advanced breast cancer
  • operable metastatic breast cancer

Exclusion Criteria:

  • patient not candidate for NAC
  • contrast allergy
  • renal impairment
  • pregnancy

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Stable
2
Partial response
3
Moderate response
4
Excellent response
5
Complete response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy of contrast enhanced spectral mamography in the predicting of pathological response to NAC and assessment residual disease in breast cancer patients
Time Frame: Basline
Basline

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess best imaging modalities in pedict post neoadjuvant response
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

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)

December 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

November 19, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CESM in breast cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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