Role of MRI Breast in Detection of Ductal Carcinoma in Situ | NCT06744140

Studies
Role of MRI Breast in Detection of Ductal Carcinoma in Situ

NCT06744140

Sponsor

Superior University

Status

Active, not recruiting

Last Update Posted

Dec 20, 2024Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Carcinoma in Situ

Interventions

Magnetic Resonance Imaging (MRI)

Countries

Pakistan

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2024Actual

Primary Completion Date

Jul 1, 2024Actual

Completion Date

Mar 21, 2025Estimated

First Submitted Date

Dec 17, 2024

First Submission Date that Met QC Criteria

Dec 17, 2024

First Posted Date

Dec 20, 2024Actual

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

Dec 17, 2024

Last Update Posted Date

Dec 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

"This study investigates the role of Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma in situ (DCIS) in high-risk breast cancer patients.

Detailed Description

Improved detection rates of DCIS in high-risk patients. Enhanced diagnostic accuracy, reducing false positives and negatives. Ductal Carcinoma in situ (DCIS) is a non-invasive breast cancer where abnormal cells are confined to the milk ducts.

The Breast Imaging Reporting and Data System (BI-RADS) is a standardized scoring system used to classify breast imaging findings. Scores range from 0 (incomplete) to 6 (known biopsy-proven malignancy)."

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

35Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance Imaging (MRI)	Diagnostic Test	To Evaluate the breast Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma In Situ (DCIS) lesions among high-risk breast cancer patients while keeping the histopathology as a GOLD standard

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensitivity & specificity	sensitivity & specificity of MRI in detecting DCIS	12 Months
BIRADS scores	BIRADS scores will be used to evaluate the diagnostic accuracy of MRI in detecting DCIS	12 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

High-risk breast cancer patients with a family history of breast cancer or genetic predispositions (e.g., BRCA mutations).
Patients aged 30-65 years.
Patients willing to undergo breast MRI screening for DCIS detection.

Exclusion Criteria:

Patients with contraindications to MRI imaging (e.g., pacemakers, claustrophobia).
Patients with a history of prior breast surgery or interventions that may interfere with imaging interpretation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

To Evaluate the breast Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma In Situ (DCIS) lesions among high-risk breast cancer patients while keeping the histopathology as a GOLD standard

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INMOL hospital		Lahore	Punjab Province		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002278	Carcinoma in Situ

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided