Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06166173 |
| Other study ID # |
BREAST TM |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2023 |
| Est. completion date |
January 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Istanbul Medeniyet University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Before neoadjuvant chemotherapy (NACT) in cases of locally advanced breast cancer, malignant
masses in the breast and biopsy-proven tumor involvement axillary lymph nodes are marked with
metallic markers. The primary objective of this marking is to establish the precise
localization of the tumor which response to NACT partial or completely. However, selecting
the marker with ultrasound (US) proves challenging in many instances. Research studies
indicate that patients with occult markers are observed at a frequency of 24%. Some studies
propose that the twinkling artifact serves as a reliable method for accurately indicating the
localization of certain tumor markers. This artifact is deemed particularly helpful for
lesions situated in the axilla or posterior of the breast, which may not be visible with US
and are undetectable with mammography.
In the context of Color Doppler examination, the investigators have noted the presence of
another color Doppler artifact which can aid in determining marker localization. When the
pulse repetition frequency (PRF) is reduced and the color gain is increased, color noise,
termed as color confusion or blooming artifact/effect, is observed within the color steer.
While this color confusion tends to mask healthy tissues, it has been observed that the tumor
marker remains unaffected by the blooming effect. Consequently, this artifact serves to
distinctly reveal the borders and localization of the tumor marker.
In some studies, it has been stated that the twinkling artifact, which is a color Doppler
artifact and whose mechanism is not fully understood, is a reliable method to accurately
indicate the localization of some tumor markers. It has been reported that this artifact will
be very helpful, especially in lesions located in the axilla or posterior of the breast,
which cannot be seen with US and cannot be detected with mammography .
In Color Doppler examination, we saw that another color Doppler artifact, such as the
twinkling artifact, could also be helpful in determining marker localization. When the PRF is
reduced and the color gain is increased, color noise, which is selected as color confusion
and can be called blooming artifact or blooming effect-like, is observed in all structures
within the color steer. While healthy tissues are masked by this color confusion, the tumor
marker is protected from the blooming effect. Thus, with this artifact, tumor marker borders
and localization are clearly revealed.
Description:
Following an exhaustive review of the existing literature, the investigators have determined
that their study stands as the first to show the utility of like blooming artifact appearance
in color Doppler US for precisely determining the localization of tumor markers placed in the
breast and axilla. There are two crucial phases in this study: Pre and post-NACT patients. In
these two stages, tumor markers could be successfully demonstrated using this artifact
(blooming artifact-like appearance). This groundbreaking finding lends support to B-mode
ultrasound (US), which demonstrates high diagnostic potential and proves valuable for
radiologists, thereby providing reassurance Post-NACT, the hypoechoic mass in the breast and
the thick-cortical lymph node in the axilla undergo shrinkage. Identifying the residual mass
becomes feasible solely with the hyperechoic marker placed before NACT. The hyperechoic
marker in the shrinking mass after NACT cannot be discerned from the hyperechoic fibrous
structures in the normal breast parenchyma. However, when the like blooming artifact is
generated in the color Doppler examination, the echogenic normal breast or axillary
parenchyma is enveloped by this artifact. Importantly, the metallic marker remains unaffected
by this artifact.
To achieve homogeneity of this artifact, specific Doppler US parameters must be applied to
the color Doppler examination window. For this artifact to be diagnostic, color Doppler US
must be provided in the all examination consistently. Consequently, while the non-marker area
is covered with the blooming artifact, the marker becomes distinctly visible.
The investigators note that while the use of twinkling artifacts in determining marker
localization is well-established, the blooming artifact utilized in this study remains
unknown. No prior literature research has explored this artifact or highlighted its
diagnostic contributions.
In this study, the investigators have aimed to mask tissues outside the marker with the
blooming artifact. Consequently, the linear marker cannot be masked and appears echogenic. In
the color Doppler US window covered with the blooming artifact, only the marker itself stands
out as a smooth linear echogenicity. This distinctive feature enables an easy examination for
determining marker localization, irrespective of the marker's structure, shape, or ambient
temperature. Therefore, it can be asserted that this method is not only easier to implement
but also more reliable compared to other techniques.
