General information about starting a Breast Density study
* Who does the set-up and when does it take place?
The set-up, training, and calibrations are done by UCSF personnel. I have been tasked with this most recently with several other sites participating. This takes place before data collection begins – immediately after the technology is installed.
* Will the practice be required to have new paddles, or can their current paddles be fitted with the phantom?
I hear your site has three GE systems. Is this correct? Of what variety (2000D and/or DS)? The phantoms are fitted on the same paddles already in use on the mammo units, but the protocol for our study requires extra unmodified paddles to be purchased in the event that our technology interferes with a normal mammogram (i.e. extremely large breasted women whose breast overlap the phantom). Do you know if your GE systems have the large paddle option? Or are they limited to only small paddles? And are all three systems at one location?
The number of extra unmodified paddles that need to be purchased depends on the modality, whether the systems have a large paddle option, and on whether the systems are in the same vicinity. The less likely the phantom will interfere with an exam, the less the number of extra paddles need to be purchased. I can provide you a list of equipment and quotes depending on these factors.
* Regarding staff training, who will be trained? How many people? What does the training entail? How long will the training take?
The site staff to be trained for this study usually includes all mammography technologists, a medical physicist, and a IT/networking engineer or study assistant. The radiologists need to be aware of the technology as well.
* What exactly will be required of the staff for this study, in terms of the impact on the daily flow of the practice?
The mammography techs are the frontline and are responsible for maximizing use of the breast density phantom with all standard screening exams every day. The only time this affects the daily work flow though, is if the phantom interferes with the imaging of a woman’s breasts. There is also a weekly study QC scan that needs to be added to the existing QC protocol of the clinic.
A medical physicist on site provides support should the phantom be detached, damaged, or if other more technical issues occur.
One image collecting workstation will need to be installed onto the same network that the mammo units reside on. Our image collecting procedures are mostly automated and even more efficient if we are given remote access to this workstation and if data transfer is done over the internet. If data is to be transferred via a physical medium, a study assistant may need to rotate out portable hard-drives monthly to UCSF.
Additional information
How much time will be spent on training the staff? Do all the techs need training?
All the techs that will be performing screening mammograms need the training, which is something between 15-30 minutes. The protocol for collecting the data for this study is exactly that of a standard screening exam, except when the phantom interferes with the imaging of relatively large breasted women.
Is this screening only or screening and diagnostic?
This is screening only. Diagnostic views usually utilize special paddles that will not be outfitted with density phantoms.
Is the phantom used for every screen/diagnostic?
The phantom sits on the screening compression paddles and are imaged with every mammogram, except where it would interfere with the image of the breast. In the event of interference, a blank compression paddle is used.
If the phantom covers breast tissue, then the unmodified paddle is used, correct? Otherwise, nothing special is needed?
Yes, you are correct. There is an additional longitudinal QC phantom that needs to be scanned weekly, but this does not affect normal screening exams at all.
Who is doing the transfer of data? An Easternrad, CMR, or USCF staffer?
This would depend on the mode of transfer. We are working toward transfers over the internet. This can be automated relatively easily. If we will use a physical medium such as external hard-drives. Someone on site in NC will have to detach a full hard-drive, send it to UCSF, and reattach a blank hard-drive.