Using handheld ultrasound to assess women with positive breast exams
Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers
This study is testing a handheld ultrasound device to see if it can help women with positive breast exams get more accurate results about whether their lumps are cancerous or not.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | Female |
| Sponsor | International Agency for Research on Cancer Academic / other |
| Locations | 1 site (Kannur) |
| Trial ID | NCT06056843 on ClinicalTrials.gov |
What this trial studies
This study evaluates the accuracy of a portable ultrasound device in distinguishing between benign and malignant breast lesions in women who have tested positive on a clinical breast examination (CBE). Given the high false-positive rates associated with CBE, this research aims to provide a more reliable and cost-effective triage method that can be utilized by non-radiologists in low- and middle-income countries. The study involves women who have been referred for further evaluation after a positive CBE, and it seeks to improve early detection of breast cancer while minimizing unnecessary procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are women who have tested positive on a clinical breast examination and do not have a confirmed diagnosis of breast cancer.
Not a fit: Patients who have already been diagnosed with breast cancer or have received treatment for the disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate breast cancer screening and reduce the psychological and financial burden on women in resource-limited settings.
How similar studies have performed: Other studies have shown promise in using portable ultrasound for breast cancer screening, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical breast examination positive women with no debilitating illness. * Symptomatic women found to be positive on clinical breast examination by nurses/midwives or medical officers. Exclusion Criteria: * Women with confirmed diagnosis of breast cancer or those already treated for the disease.
Where this trial is running
Kannur
- Malabar Cancer Care Society Kannur — Kannur, India (Recruiting)
Study contacts
- Study coordinator: Farida Selmouni, PhD
- Email: SelmouniF@iarc.who.int
- Phone: + 33 4 72 73 84 99
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.