Accuracy Of Contrast Enhanced Mamography in Predicting Re... | NCT05141279

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

NCT05141279

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 2, 2021Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Estimated

Primary Completion Date

Dec 1, 2023Estimated

Completion Date

Jan 1, 2024Estimated

First Submitted Date

Nov 19, 2021

First Submission Date that Met QC Criteria

Nov 19, 2021

First Posted Date

Dec 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2021

Last Update Posted Date

Dec 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Stable
2		Partial response
3		Moderate response
4		Excellent response
5		Complete response

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided