Role of MRI Breast in Detection of Ductal Carcinoma in Situ

December 17, 2024 updated by: Muhammad Naveed Babur, Superior University
"This study investigates the role of Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma in situ (DCIS) in high-risk breast cancer patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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)."

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • INMOL hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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

Description

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.

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Superior 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 (Actual)

February 15, 2024

Primary Completion (Actual)

July 1, 2024

Study Completion (Estimated)

March 21, 2025

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSAHS/Batch-Spring23/018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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