Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06049446 |
| Other study ID # |
CEMMAG |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 8, 2023 |
| Est. completion date |
June 10, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Zuyderland Medisch Centrum |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Rationale: 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. The 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 alternative
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.
Objective: To test whether the use of magnetic localization seeds causes image artifacts on
CEM.
Study design: Observational feasibility study.
Study population: Women (>18 years) able to provide written informed consent and recently
diagnosed with (non-palpable) breast cancer or ductal carcinoma in situ (DCIS), who are
primarily treated with surgery.
Intervention (if applicable): Image-guided placement of a magnetic seed (Sirius Pintuition)
prior to surgery, including control imaging to confirm the correct location of the seed
relative to the breast abnormality. In usual patient care this is performed with full-field
digital mammography (FFDM), but in this study this control image will be performed with the
system in 'contrast-enhanced mammography' or CEM mode, but without using intravenous
administration of iodinated contrast agent because the purpose is not repetition of
diagnostic imaging, but to rule out any artifacts caused by the seed on CEM. The
investigators estimate to include twenty patients to confidently test the hypothesis that
magnetic seeds do not cause disturbing artifacts on CEM examinations.
Main study parameters/endpoints: The primary study aim will be to test whether the magnetic
seeds caused any disturbing artifacts on CEM images. As secondary study, the investigators
will document technical success rate of seed deployment and retrieval during surgery,
including the assessment of the surgical margins (positive or negative).
Description:
Rationale: 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 alternative 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.
Objective: To test whether the use of magnetic localization seeds causes image artifacts on
CEM.
Study design: Observational feasibility study. Study population: Women (>18 years) able to
provide written informed consent and recently diagnosed with (non-palpable) breast cancer or
ductal carcinoma in situ (DCIS), who are primarily treated with surgery.
Intervention (if applicable): Image-guided placement of a magnetic seed (Sirius Pintuition)
prior to surgery, including control imaging to confirm the correct location of the seed
relative to the breast abnormality. In usual patient care this is performed with full-field
digital mammography (FFDM), but in this study this control image will be performed with the
system in 'contrast-enhanced mammography' or CEM mode, but without using intravenous
administration of iodinated contrast agent because the purpose is not repetition of
diagnostic imaging, but to rule out any artifacts caused by the seed on CEM. The
investigators estimate to include twenty patients to confidently test the hypothesis that
magnetic seeds do not cause disturbing artifacts on CEM examinations.
Main study parameters/endpoints: The primary study aim will be to test whether the magnetic
seeds caused any disturbing artifacts on CEM images. For this purpose, two 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. The radiologists will
assess the images independently first, and consensus opinion is formed should any
discrepancies occur in their judgement. As secondary study, the investigators will document
technical success rate of seed deployment and retrieval during surgery, including the
assessment of the surgical margins (positive or negative).
Nature and extent of the burden and risks associated with participation, benefit, and group
relatedness: 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, the investigators 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.
