Cancer
Conditions
Interventions
Wide Bore Needle Aspiration Biopsy for Histology
Sponsors
Association of Radiation and Clinical Oncologists of Nigeria
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women aged =18 years Presence of a suspicious, solid breast mass (BI-RADS 4 or 5) confirmed by ultrasound, measuring =2 cm in maximum diameter. This threshold minimizes the risk of sampling failure or histologic inadequacy, given the paired-sample design requiring two biopsies per lesion. Ability to provide informed consent Willingness to complete follow-up procedures
Exclusion criteria
Exclusion criteria: Coagulopathy, bleeding disorder Use of anticoagulants or antiplatelets (except low-dose aspirin) Active breast infection or skin ulceration Inability or unwillingness to provide informed consent or complete follow-up procedures Lesions <2 cm in size.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure completion rate- Proportion of biopsy procedures successfully completed as per protocol ;Retention rate- Proportion of enrolled participants who complete both Wide-NAB and CNB procedures and follow-up assessments. ;Sample adequacy- Proportion of biopsy samples yielding sufficient tissue for definitive histopathological diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure duration – Total time (in minutes) from needle insertion to completion of sample retrieval. ;Sample yield (radiologist-graded) – Visual adequacy based on apparent core size (=0.2 cm), color consistency with soft tissue, and whether the core sinks in formalin. ;Device malfunction rate – Frequency of mechanical failure or functional inadequacy of the biopsy device during use. ;Tissue adequacy (pathologist-graded): Assessed by the sufficiency of lesional tissue present, using the predefined 4-point grading scale detailed in the pathology evaluation section. ;Diagnostic concordance – Agreement between histopathological results of Wide-NAB and CNB, assessed using Cohen's kappa coefficient. ;Exploratory diagnostic accuracy- Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) among participants who undergo surgical excision biopsy, used as the reference standard. ;Patient-reported pain – Assessed post-procedure using the Numeric Rating Scale (NRS). ;Patient-reported satisfaction – Assessed using a 5-point Likert scale. | — |
Countries
Nigeria
Contacts
Public ContactAkinola Odedeyi
Consultant Radiologist Obafemi Awolowo University Teaching Hospitals Complex
Outcome results
None listed