To test whether the use of magnetic localization seeds causes image artifacts on CEM.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study aim will be to test whether the magnetic seeds caused any
disturbing artifacts on CEM images. For this purpose, two blinded radiologists
will score the images for the presence of any artifacts and if present, if
these are to such an extent that they would hamper diagnostic evaluation of the
images.
Secondary outcome
As secondary study, we will document technical success rate of seed deployment
and retrieval during surgery, including the assessment of the surgical margins
(positive or negative).
Background summary
Breast cancer patients are increasingly treated with neoadjuvant chemotherapy
for various reasons. These women receive chemotherapy before any surgery is
performed. Many of these tumors need preoperative seed localization to help
guide the surgeons to the site of the tumor within the breast. In many
hospitals, a radioactive I-125 seed is used for this purpose, which has several
disadvantages, such as a slight increase in radiation dose and extensive
administrative regulations to monitor the location of the seed at any time
(required by law). This administrative work is time consuming, elaborate and
prone to errors. Therefore, interest is shifting towards to use of
non-radioactive seeds, such as the magnetic seeds used in this study. A
drawback of these seeds is the fact that they cause large susceptibility
artifacts on (magnetic!) MRI of the breast. Breast MRI is the most accurate
modality to monitor response to therapy of these women. CEM, an emerging breast
imaging technique, has shown to achieve comparable results with regard to
response monitoring but uses no magnetic fields. Hence, CEM might be an
attractive alternate response monitoring tool in patients treated with
neoadjuvant chemotherapy and having a magnetic seed a surgical marker. To this
point, however, no study in humans has confirmed that this is indeed the case.
Study objective
To test whether the use of magnetic localization seeds causes image artifacts
on CEM.
Study design
Observational feasibility study.
Study burden and risks
The burden and risk for participating subjects are very small. In regular care,
a radioactive I-125 seed is placed in the breasts of these women, checking the
position with (conventional) FFDM. For this purpose, the iodine seed is
replaced with a (radioactive-free) magnetic seed (Sirius Pintuition). The
latter did not show any relevant imaging artifacts prior to this study in
imaging phantoms (i.e., chicken breasts containing magnetic seeds). Therefore,
we feel confident that these seeds will not show artifacts on clinical CEM
image, but this needs to be confirmed before additional studies regarding the
clinical application of CEM and magnetic seeds combined can be safely
performed. The only additional disadvantage for participants is the slight
increased radiation dose of the (extra) high-energy image CEM image, which is
an increased radiation dose to the breasts of 50-80%. However, these women are
all diagnosed with breast cancer requiring adjuvant radiotherapy, which uses
radiation doses much, much higher than a single mammographic exposure.
Dr. H. van der Hoffplein 1
Geleen 6162BG
NL
Dr. H. van der Hoffplein 1
Geleen 6162BG
NL
Listed location countries
Age
Inclusion criteria
Women scheduled for breast conservative therapy for a non-palpable breast
lesion requiring image-guided localization using a magnetic seed.
Exclusion criteria
Unable to provide written informed consent. Age <18 years. Pregnancy.
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 | NL83090.096.22 |