Breast MRI in Evaluation of Pathologic Response in Patien... | NCT05301790

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

NCT05301790

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 31, 2022Actual

Enrollment

45Estimated

Phase

Not provided

Conditions

Role of MRI in Evaluation of Breast Cancer

Interventions

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

Mar 2022

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

May 2022Estimated

Primary Completion Date

Jun 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Mar 20, 2022

First Submission Date that Met QC Criteria

Mar 20, 2022

First Posted Date

Mar 31, 2022Actual

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

Mar 20, 2022

Last Update Posted Date

Mar 31, 2022Actual

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

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

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

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

45Estimated

Name	Type	Description	Arm Group Labels	Other Names
MRI	Device	use of MRI modality of imaging in evaluation of pathologic response in patients with breast cancer

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Doaa Maher, resident	Contact	01050147500		dm953407@gmail.com
hasan megally, professor	Contact	01006209584		hasanibrahim48@yahoo.com

Overall Officials

Name	Affiliation	Role
lamiaa mohamed refaat, assisstant professor	assiut university -south egypt cancer institute	Study Director
omar mostafa, lecturer	assiut university-south egypt cancer institute	Study Director

Locations

Not provided