NCT07033507 Diffusion Coefficient and Micro-calcifications to Kaiser Score in Evaluation of BI-RADS 4 Breast Lesions
| NCT ID | NCT07033507 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mansoura University Hospital |
| Condition | Breast Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-06-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Breast cancer is the most commonly diagnosed cancer worldwide and is the leading cause of cancer-related deaths in women. Mammography, breast ultrasonography (US), and breast magnetic resonance imaging (MRI) are essential for the diagnosis and follow-up of breast cancer. The American College of Radiology Breast Imaging- Reporting and Data System (ACR BI-RADS), which is used worldwide, provides the standard terminology for breast imaging (Jajodia et al., 2021). The ACR BI- RADS lexicon categorizes breast imaging findings into seven BIRADS categories of 0, 1, 2, 3, 4(4a, 4b, 4c), 5, and 6 according to the probability of malignancy. Breast imaging findings assigned as BI-RADS 4 require tissue sampling and histopathological examination. However, the likelihood of malignancy of lesions classified as BI-RADS 4 ranges widely, from 3% to 94%. Categorization of lesions according to BI-RADS is related to the experience of the radiologist, with experienced radiologists performing better than inexperienced radiologists
Eligibility Criteria
Inclusion Criteria: * Patients with BI-RADS 4 lesion. Exclusion Criteria: * Patients on chemotherapy or related treatment. * Patients who have contraindications to do MRI as patients with cardiac pace maker, patients with cochlear implant and ocular foreign body, claustrophobia.
Contact & Investigator
Mohamed AbdElmoniem
PRINCIPAL INVESTIGATOR
Lecturer of faculty of medicine Mansoura university
Frequently Asked Questions
Who can join the NCT07033507 clinical trial?
This trial is open to female participants only, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07033507 currently recruiting?
Yes, NCT07033507 is actively recruiting participants. Contact the research team at dr.m1993@mans.edu.eg for enrollment information.
Where is the NCT07033507 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt.
Who is sponsoring the NCT07033507 clinical trial?
NCT07033507 is sponsored by Mansoura University Hospital. The principal investigator is Mohamed AbdElmoniem at Lecturer of faculty of medicine Mansoura university. The trial plans to enroll 80 participants.