Clinical trial NCT06494865: " Role of Diffusion Weighted Image in the Diagnosis and Follow up of Breast Cancer"
Official title: " Role of Diffusion Weighted Image in the Diagnosis and Follow up of Breast Cancer"
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_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.

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.

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.

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

Primary outcomes:
measure: Rate of correlated false positive results of MRI DWI for the lesion with the positive results by histopathology.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.