Mammogram Scheduled Clinical Trial
Official title:
Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Breast Augmentation
Purpose:The aim of this research is to compare the 3D s-DBT (stationary digital breast
tomosynthesis) and conventional 2-D digital mammography devices with regards to patient
comfort and radiologist preference in women with breast implants.
Participants: Women with breast implants undergoing routine 2-D digital mammography.
Procedures (methods): 50 female subjects with breast implants undergoing conventional
screening mammography will be recruited to have a single view s-DBT in the mediolateral
projection. We will perform a patient preference study and radiologist reader study composed
of radiologists who have experience evaluating tomosynthesis images. A short survey will be
given to each patient about their preference in modality with respect to comfort. Each reader
will review the images and score the ease of interpretation, and their confidence of
interpretation.
Patients will be recruited with assistance from a referring physician and through patients
undergoing routine mammography in the breast imaging clinic.
All eligible women will be contacted by letter and/or phone call prior to scheduled
mammography appointment to identify if they would be interested in participating in the
research study. On the day of their conventional mammographic imaging, the study will be
explained, and they will be offered the opportunity to participate. Consent will happen in a
private room in the mammography clinic.
Once consent has been signed, a urine sample will be collected from women who can still
become pregnant in order to complete a pregnancy test. Women who are pregnant are unable to
participate in this study.
Women who consent for the study will be escorted by the research coordinator to a dressing
room, where the subject will change into a gown. The research coordinator or research
technologist will then escort the participant to the dedicated study room for the imaging
exam. The patient will have the SDBT study performed in a similar manner as conventional
mammography in the mediolateral oblique and cranio-caudal plane. The participant will stand
up and the mammography research technologist, ensuring patient comfort, will assist in
positioning their breast in the breast tomosynthesis unit with standard compression. Once
positioned, the total scan time is approximately 10 seconds. Both the left and right breast
will be imaged. The length of time for the positioning and examination of a subject's breast
may vary but it is expected that the entire imaging procedure will take about 5-10 min,
including positioning time.
The breast tomosynthesis scan will be acquired at a dose that is equal to or less than a
diagnostic mammogram dose. Upon completion of the breast tomosynthesis exam, the research
assistant will provide a short survey to be completed by the patient (less than 5 minutes).
The survey will include questions such as the comfort level of s-DBT compared to the standard
mammography.
The research SDBT exam will NOT be interpreted prior to the patient leaving the clinic.
However, since there is theoretically a possibility of detecting an additional lesion not
seen on conventional mammography, all images will be reviewed within a week by a qualified
breast imaging specialist. If there are lesions of concern, these will be discussed with the
referring surgeon or the patient's primary physician.
After completion of the patient acquisition, a reader study will be performed with five
qualified radiologists.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02108314 -
Video-assisted Intervention for Increasing Mammography Uptake in Private Primary Care in Singapore
|
N/A | |
| Completed |
NCT02493595 -
Synthetic Aperture Radar Detection of Breast Tumours
|