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Not yet recruiting NCT06494865

" Role of Diffusion Weighted Image in the Diagnosis and Follow up of Breast Cancer"

Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI device.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

Most of the lesions that occur in the breast are benign lesions. It is important to recognize benign lesions and distinguish them from breast cancer.

Nowadays sonomammography still represents the primary imaging modality utilized for breast cancer screening and diagnosis.

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.Diffusion weighted imaging provides micro-structural informations regadrding the diffusion of the water molecules in the tissue cellularity and tissue structure by using the quantitive analysis with the apparent diffusion coefficient (ADC) values.

Using Diffusion weighted imaging (DWI) combined to MRI is helpful to distinguish malignant versus benign breast lesions and it also may reduce the number of unnecessarily breast biopsies.

Interventions

  • Device MRI device
    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

Primary outcome measures

  • Rate of correlated false positive results of MRI DWI for the lesion with the positive results by histopathology. [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 31554551
  • 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 29455658
  • 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 28802529
  • 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 30039037

Identifiers

NCT: NCT06494865 · soh-Med-24-06-23MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗