NCT06494865

Brief Summary

Breast MRI has become an important tool for breast cancer detection and characterization.Contrast enhanced MRI(CE-MRI) is currently the most sensitive detection technique for diagnosis of breast cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Status
not yet 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

First Submitted

Initial submission to the registry

July 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

July 2, 2024

Last Update Submit

August 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of correlated false positive results of MRI DWI for the lesion with the positive results by histopathology.

    evaluation of the lesion with MRI DWI and histopathology for detect rate of false posive results

    6 months

Interventions

Standered breast coils with small field of veiw and thin sections will be used for the examinatio. MRI breast including Axial T1WI, T2WI Stir contrast DWI and Stir sagittal T1WI with contrast traction and subtraction

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female gender * Age more than 18 years * Patients presented with breast lump * Pateints with recurrent breast cancer following chemotherapy or radiotherapy sessions.

You may qualify if:

  • \* Female gender
  • Age more than 18 years
  • Patients presented with breast lump
  • Patients with recurrent breast cancer following chemotherapy or radiotherapy sessions.

You may not qualify if:

  • Male gender
  • Age younger than 18 years
  • Patients with recent breast trauma in the same diseased breast within the last 6 months
  • Lactating female presented with acute symptoms as trauma or breast abscess
  • Contraindication to perform MRI examination .these include : Cardiac pacemaker -Metallic aneurysm clips

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Stachs A, Stubert J, Reimer T, Hartmann S. Benign Breast Disease in Women. Dtsch Arztebl Int. 2019 Aug 9;116(33-34):565-574. doi: 10.3238/arztebl.2019.0565.

    PMID: 31554551BACKGROUND
  • Butti R, Das S, Gunasekaran VP, Yadav AS, Kumar D, Kundu GC. Receptor tyrosine kinases (RTKs) in breast cancer: signaling, therapeutic implications and challenges. Mol Cancer. 2018 Feb 19;17(1):34. doi: 10.1186/s12943-018-0797-x.

    PMID: 29455658BACKGROUND
  • Shi RY, Yao QY, Wu LM, Xu JR. Breast Lesions: Diagnosis Using Diffusion Weighted Imaging at 1.5T and 3.0T-Systematic Review and Meta-analysis. Clin Breast Cancer. 2018 Jun;18(3):e305-e320. doi: 10.1016/j.clbc.2017.06.011. Epub 2017 Jul 5.

    PMID: 28802529BACKGROUND
  • Yilmaz E, Sari O, Yilmaz A, Ucar N, Aslan A, Inan I, Parlakkilic UT. Diffusion-Weighted Imaging for the Discrimination of Benign and Malignant Breast Masses; Utility of ADC and Relative ADC. J Belg Soc Radiol. 2018 Feb 7;102(1):24. doi: 10.5334/jbsr.1258.

    PMID: 30039037BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Mennatullah A Ibrahim, resident

CONTACT

Medhat I Mohammed, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident-radiology department-sohag hospital university

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 10, 2024

Study Start

August 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08