A study of a new ultrasound scan to check if breast lumps are safe or risky
| ISRCTN | ISRCTN11338253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11338253 |
- Submission date
- 08/09/2025
- Registration date
- 17/09/2025
- Last edited
- 16/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study is looking at a new way to help doctors decide whether a lump in the breast might be cancerous. Right now, ultrasound scans are commonly used, but they don’t always give a clear answer. The researchers are testing a technique called “elastography,” which measures how stiff the lump is. Stiffer lumps are more likely to be cancerous. The aim is to see if elastography can improve diagnosis and reduce unnecessary biopsies.
Who can participate?
Women who have been found to have a breast lump that looks uncertain (but not highly suspicious) on a regular ultrasound scan—specifically those classified as BI-RADS 3 or 4a—may be invited to take part.
What does the study involve?
If you agree to take part, a trained sonographer will perform an additional scan using elastography. This scan is painless and non-invasive. Afterwards, you’ll have a core needle biopsy, which is the standard way to check if a lump is cancerous. The results from the scans and biopsies will be compared, but the people doing each test won’t know the results of the other to keep things fair.
What are the possible benefits and risks of participating?
There’s no direct benefit to you, but your participation could help improve how breast lumps are diagnosed in the future. The elastography scan is safe and non-invasive. The biopsy is a routine procedure, but like any medical test, it carries small risks such as bruising or infection.
Where is the study run from?
Erbil breast center (Iraq)
When is the study starting and how long is it expected to run for?
July 2024 to July 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Nasik Majeed, drnasik21@gmail.com
Contact information
Public, Scientific, Principal Investigator
40 m street beside Cihan Bank
Erbil
-
Iraq
 ORCID ID |
0000-0003-3350-657X |
|---|---|
| Phone | +964 7504905284 |
| drnasik21@gmail.com |
Study information
| Study design | Prospective diagnostic accuracy study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Diagnostic Accuracy of Sound Touch Elastography Versus Conventional Ultrasound in BI-RADS 3 and 4a Breast Masses |
| Study objectives | The objective of this study is to evaluate the role of sound touch elastography, quantification, and shear ratio in breast mass classification. It assesses whether incorporating them into ultrasound for BI-RADS 3 and 4a masses can improve category upgradation or down-gradation. |
| Ethics approval(s) |
Approved 06/08/2025, Research Ethics Committee (College of medicine- Hawler medical university- Khanzad street, Erbil, -, Iraq; +964 7507791292; ruqaya.taher@hmu.edu.krd), ref: 11 |
| Health condition(s) or problem(s) studied | Patients with breast masses, BIRADS 3 and 4 |
| Intervention | Patient eligibility verified, informed consent obtained, demographics and clinical history recorded, and clinical breast exam performed. Conventional ultrasound with BI-RADS assessment done, we selected BI RADS 3 and 4a breast masses for our study and further assessment by Sound Touch elastography for the mass and shell, recording quantitative metrics (Emax, Emean, STQ), and shear ratio (lesion-to-fat ). The data saved and completed questionnairre form. (Total time for imaging session: ~30–60 minutes.) If BI-RADS 4a: we arranged ultrasound-guided core-needle biopsy within 7 days. . If BI-RADS 3: ultrasound-guided core-needle biopsy arranged for patients with positive family history of breast cancer, on surgeon's request, or on request of health-concious patients The histopathology result (returned within 7–14 days) for the final diagnosis |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Breast masses assessed using a single measurement of ultrasonography, as well as a separate singular measurement using elastography 2. Additional information collected through a questionnaire detailing the patient’s medical history |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 15/07/2024 |
| Completion date | 25/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 17 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | 184 |
| Total final enrolment | 133 |
| Key inclusion criteria | Patients with BIRADS 3 and 4 breast masses with sizes between 5-30 mm |
| Key exclusion criteria | 1. Masses less than 5 mm and larger than 30 mm 2. Refused biopsy 3. Pregnant or lactating women 4. Breast with implant or scar 5. Masses stable for more than one year |
| Date of first enrolment | 05/10/2024 |
| Date of final enrolment | 10/07/2025 |
Locations
Countries of recruitment
- Iraq
Study participating centre
Erbil
-
Iraq
Sponsor information
University/education
College of Medicine, Hawler Medical University
Khanzad Street, Near Hawler Teaching Hospital
Erbil, Kurdistan Region
Erbil
P.O. Box 40/0112
Iraq
| Phone | +964 66 222 7275 |
|---|---|
| medicine@hmu.edu.krd | |
| Website | https://www.hmu.edu.krd/colleges/college-of-medicine |
"ROR" |
https://ror.org/02a6g3h39 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (see study outputs) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | SAPP sav file | 15/09/2025 | No | No | |
| Dataset | zip file of docx files. Questionnaires | 15/09/2025 | No | No |
Additional files
- 47965 DATA spss 133 cases.sav
- SAPP sav file
- 47965 Raw data questionnaires.zip
- zip file of docx files. Questionnaires
Editorial Notes
15/09/2025: Trial's existence confirmed by Hawler Medical University.
