Using Doppler ultrasound resistive index to distinguish benign and malignant breast masses
A Novel Approach to the Evaluation of Breast Masses Using Doppler Ultrasonography: Percentage Changes in Resistive Index Between the Mass and Surrounding Normal Parenchyma in Benign-Malignant Differentiation
Karamanoğlu Mehmetbey University · NCT07465523
This study will test whether comparing Doppler resistive index values from a breast mass and nearby healthy breast tissue can help tell if a solid breast lump in women is benign or malignant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Karamanoğlu Mehmetbey University (other) |
| Locations | 1 site (Karaman, Lütfen Seçiniz.) |
| Trial ID | NCT07465523 on ClinicalTrials.gov |
What this trial studies
The study records minimum, maximum, and average Doppler resistive index (RI) values from solid breast masses, adjacent healthy tissue, and the opposite breast, then calculates relative RI differences between mass and healthy tissue. Cases are classified by pathology into benign and malignant groups and threshold RI differences that separate these groups will be determined. In addition, vascular index measurements using Doppler Microvascular Flow imaging will be calculated for each mass to add microvascular information. The design is observational and excludes cystic or hypovascular masses and cases with mastitis.
Who should consider this trial
Good fit: Women with solid breast masses who have or will have pathology results (biopsy/surgical pathology) are ideal candidates.
Not a fit: Patients with cystic or hypovascular lesions, active mastitis, or without confirmatory pathology results are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve noninvasive differentiation of benign and malignant breast masses and potentially reduce unnecessary biopsies.
How similar studies have performed: Prior Doppler RI studies have shown mixed but promising results for distinguishing benign from malignant lesions, and combining relative RI differences with Doppler Microvascular Flow is a relatively newer approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Those with solid breast masses * Female patients * Those with pathology results Exclusion Criteria: * Hypovascular masses * Cystic breast masses * Cases with mastitis
Where this trial is running
Karaman, Lütfen Seçiniz.
- Karamanoğlu Mehmetbey University, KEAH — Karaman, Lütfen Seçiniz., Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Ahmet Yeşildağ, Prof.Dr
- Email: ahmetysd@hotmail.com
- Phone: +905057728297
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Neoplasm Female, Benign Breast Neoplasm, Malign Breast Neoplasm, Doppler Ultrasound Diagnosis, Breast Mass, Doppler Ultrasound, B-Mode Ultrasound, Resistive Index