To investigate the clinical diagnostic performance of (extremely) low-dose views in standard digital mammography and relate this to physical image quality measures.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pathology detection, diagnostic quality (subjective), image quality (objective)
Secondary outcome
Lesion type, BIRADS category, need for additional imaging, image noise
Background summary
An increasing number of women undergo an also increasing amount of mammographic
examinations for varying purposes. However, every mammogram adds to a woman*s
life-time radiation exposure with subsequent risks.
Due to the possibilities of tailored image processing in digital mammography,
reducing radiation dosage, while preserving diagnostic performance, is more
realistic than ever before. Thus far only phantom studies have been performed
in this field and the relationship between physical image quality measures and
diagnostic performance is poorly understood.
Outcomes of our pilot study with mastectomy specimens suggest a possible 80%
dose reduction in mammographic images in real practice. We therefore
hypothesise that performing digital mammography with only a full radiation dose
mediolateral oblique (MLO) view and all additional views obtained with a
markedly reduced dose will not significantly affect the diagnostic accuracy.
Obtaining low-dose images in addition to a high-dose MLO decreases life-time
exposure to radiation and might contribute to breast cancer detection by
lowering the threshold for obtaining additional images in the diagnostic as
well as the screening setting.
Study objective
To investigate the clinical diagnostic performance of (extremely) low-dose
views in standard digital mammography and relate this to physical image quality
measures.
Study design
We propose an observational performance (proof-of-principle) study in the
hospital setting. In addition to a standard clinical mammogram (MLO and
craniocaudal (CC) view) a low-dose CC-view will be performed. Both exam
combinations (MLO & low-dose CC, and MLO & full dose CC) will be interpreted
independently by three experienced radiologists. Differences in clinical
outcome will be analysed in order to determine the diagnostic performance of
low-dose CC images in digital mammography. These clinical results will further
be related to objective physico-technical measurements of image quality.
Study burden and risks
There is no direct risk in participating, since it encompasses a known and
standardised diagnostic procedure. However, the extended procedure does come
with lengthening of breast compression time and possible physical discomfort.
Since a markedly reduced dose is used for the additional study images
associated indirect (stochastic) effects of additional radiation images might
be negligible.
Analysing the potential of radiation reduction in a widely and frequently used
procedure such as mammography may benefit the entire female population, and
therefore the participant as well in case of future mammography examinations.
Weg door Jonkerbos 90
6532 SZ Nijmegen
NL
Weg door Jonkerbos 90
6532 SZ Nijmegen
NL
Listed location countries
Age
Inclusion criteria
female, scheduled mammography, age > 30 years, every clinical indication, every ethnicity
Exclusion criteria
no informed consent, male, age < 30 years, pregnancy, lactation, extreme mastodynia, physical conditions that restrict the mammographic assessment (e.g. paralysis, stiffness)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32234.008.10 |