NCT06744140

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

February 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2025

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 17, 2024

Last Update Submit

December 17, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

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

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INMOL hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Carcinoma in Situ

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

February 15, 2024

Primary Completion

July 1, 2024

Study Completion

March 21, 2025

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations