- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06494865
" Role of Diffusion Weighted Image in the Diagnosis and Follow up of Breast Cancer"
Study Overview
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mennatullah A Ibrahim, resident
- Phone Number: 01015003865
- Email: menaashraf@med.sohag.edu.eg
Study Contact Backup
- Name: Medhat I Mohammed, professor
- Phone Number: 01014005636
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Female gender
- Age more than 18 years
- Patients presented with breast lump
- Pateints with recurrent breast cancer following chemotherapy or radiotherapy sessions.
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of correlated false positive results of MRI DWI for the lesion with the positive results by histopathology.
Time Frame: 6 months
|
evaluation of the lesion with MRI DWI and histopathology for detect rate of false posive results
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- soh-Med-24-06-23MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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