NCT05141279

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

November 19, 2021

Last Update Submit

November 19, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Accuracy of contrast enhanced spectral mamography in the predicting of pathological response to NAC and assessment residual disease in breast cancer patients

    Basline

Secondary Outcomes (1)

  • Assess best imaging modalities in pedict post neoadjuvant response

    Baseline

Study Arms (5)

1

Stable

2

Partial response

3

Moderate response

4

Excellent response

5

Complete response

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doaa Mahmoud Ahmed

Study Record Dates

First Submitted

November 19, 2021

First Posted

December 2, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

December 2, 2021

Record last verified: 2021-11