We propose to perform a prospective trial to compare the accuracy of breast CT to the current standard imaging technologies for diagnosis of breast cancer in patients with a suspicious lesion identified during breast cancer screening.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in ROC area under the curve of breast CT vs. standard work-up for
diagnosis of breast cancer.
Secondary outcome
Sub-analysis for difference in ROC area under the curve of breast CT vs.
standard work-up for diagnosis of breast cancer divided by type of lesion.
Background summary
Of the many novel imaging technologies being developed for breast cancer
imaging, dedicated breast computed tomography (BCT) is one of very few that
results in a true tomographic image of the breast with high contrast resolution
and does not require the injection of a contrast agent or radiopharmaceutical.
This makes it ideal for use as the frontline imaging technology for working up
suspicious lesions detected during breast cancer screening or during clinical
breast examination.
Study objective
We propose to perform a prospective trial to compare the accuracy of breast CT
to the current standard imaging technologies for diagnosis of breast cancer in
patients with a suspicious lesion identified during breast cancer screening.
Study design
Prospective single arm study with all participants undergoing standard of care
plus breast CT. Observer study will retrospectively evaluate breast CT and
standard images and recommendations for biopsy/no biopsy compared to final
clinical outcome.
Study burden and risks
In addition to the imaging performed as the standard of care, participants will
be imaged with the breast CT system. Imaging involves 5 minutes for positioning
and 10 seconds for the actual image acquisition. The rest of the time burden
involves providing the subjects with the information on the study, answering
their questions, and obtaining informed consent. The risk associated with the
radiation involved is similar to that of the standard diagnostic work-up, since
the level of radiation dose is similar. There is no direct benefit to the
participants, but the benefit to the society involves the investigation of a
new imaging technology to improve the diagnosis of breast cancer after
screening.
Geert Grooteplein 10
NIJMEGEN 6525 GA
NL
Geert Grooteplein 10
NIJMEGEN 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Women age 35 or older
- Women scheduled to undergo a diagnostic work-up following an abnormal
screening mammogram (BI-RADS 0) with the suspicious finding NOT located in the
axillary tail of the breast.
- Women who underwent diagnostic work-up following an abnormal screening
mammogram and were assigned a BI-RADS 4 or 5 due to soft tissue lesions, or due
to microcalcifications with the suspicious finding NOT located in the axillary
tail of the breast.
Exclusion criteria
- Women who do not meet the inclusion criteria
- Women with suspected or confirmed pregnancy
- Women who have had bilateral mastectomy
- Women whose suspicious lesion is located in the axillary tail
- Women with prior breast cancer or breast biopsy in the recalled breast in the
last 12 months
- Women with palpable lesions
- Women who are breastfeeding
- Women who are very frail and unable to cooperate
- Women who cannot give informed consent
- Male subjects
Design
Recruitment
Medical products/devices used
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 | NL55378.091.15 |