NCT03870659

Brief Summary

Breast cancer is one of the leading causes of death among women, with early detection being the key to improve prognosis and survival. Randomized controlled trials have found that screening mammography has decreased the mortality of breast cancer by 30%. However, with a sensitivity of 70%, mammography has its limitations particularly in women with dense breasts. The use of breast MRI for screening has increased over the past decade. Most experiences exist in women at elevated familial risk of breast cancer. In these women, MRI screening shifts the stage distribution of breast cancers toward lower stages and reduces the fraction of interval cancers. Kuhl et al in 2014 were the first to report on the feasibility of an abbreviated breast MRI protocol for breast cancer screening. Their protocol consisting of an unenhanced T1-weighted and first contrast-enhanced T1-weighted sequence, subtraction imaging, and a single MIP image. This groundbreaking study found that image acquisition and interpretation time could be reduced without having a negative impact on diagnostic accuracy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

March 8, 2019

Last Update Submit

July 18, 2023

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

  • To evaluate accuracy of abbreviated breast MRI in cancer detection

    Sensitivity and specificity of abbreviated breast MRI in detection of cancer will be calculated and compared to those of the full protocol

    2 years

Interventions

Breast MRIRADIATION

Magnetic resonance imaging to the breast

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women referred for performing breast MRI to exclude presence of breast cancer and their lesion characterization

You may qualify if:

  • \- All women referred to our radiology department at assiut university hospital for performing breast MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zahraa

Asyut, Egypt

Location

Study Officials

  • Abeer, PhD

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 12, 2019

Study Start

April 1, 2019

Primary Completion

June 30, 2020

Study Completion

March 15, 2022

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

EG(1)