Breast Cancer, Breast Cancer Female
Conditions
Keywords
breast ultrasound, breast cancer, breast biopsy, breast cancer diagnosis, 21-325, Memorial Sloan Kettering Cancer Center
Brief summary
The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies. Researchers will use mHealth devices to create a sustainable and practical way of training radiologists in Nigeria to perform and clinically implement US-guided breast biopsies into their practice.
Interventions
PROCEDUREmHealth US-breast biopsy
During this study, women will undergo an US-guided breast biopsy by a radiologist instead of what is typically performed in Nigerian hospitals, which is either a blind biopsy or surgical excision. US-guided breast biopsy is the standard of care in the United States of America because the accuracy is better than blind biopsy and equal to surgical excision.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 and older female. * Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the Nigerian hospital where the patient is seeking diagnosis.
Exclusion criteria
* Participants unwilling to sign consent. * Participants under the age of 18.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of successful US-guided breast biopsy | 1 year | Trainees will be evaluated using a passing criterion of 80% on a validated test that assesses competency based on the The Ottawa Surgical Competency Operating Room Evaluation (O-Score). There are 8 variables rated on a scale of 1-5. A trainee will be given a passing grade if the responses on all 8 variables are 4 or 5 and this is achieved in at least 80% of the unsupervised simulation and patient biopsies. |
Countries
Nigeria, United States
Contacts
Primary ContactElizabeth Sutton, MD
Backup ContactYolana Bryce, MD
Outcome results
None listed