Breast CancerNCT06166173
Using Color Doppler US Artifact to Identify Tumor Markers
An observational study of Breast Cancer and Interventional Radiology, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Interventional Radiology, Doppler Ultrasound
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to Jan 2024
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with breast cancer and/or pathologically proven axillary lymph node involvement and who are planned or have received NACT
Who may be able to join
- patients who have breast cancer and will receive NACT,
- patients who are scheduled for breast-conserving surgery,
- those who are not allergic to metals
Who cannot join
- patients with breast cancer for whom NACT is not planned,
- patients with bleeding disorders, patients with metallic allergies,
- patients with cooperation problems and those who cannot remain still during US
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Color Doppler US Artifact to Identify Localization of Breast and Axilla Tumor Markers
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.
Read more
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.
Read the detailed 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.
- Conditions
- Breast Cancer, Interventional Radiology, Doppler Ultrasound
- Keywords
- breast cancer, tumor marker, doppler ultrasound, neoadjuvan chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast tumor | Female patients with breast tumors and/or axillary lymph node metastases who had markers placed before neoadjuvant chemotherapy (NACT), and patients undergoing preoperative marker localization after NACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Easier localization of breast tumor marker with Doppler ultrasound findings in approximately 20 patients
Use of Doppler US artifacts as an auxiliary diagnostic method in cases where tumor markers in the breast and axilla cannot be detected with conventional US.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Aug 2023
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Asik, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166173
- Sponsor's protocol ID
- BREAST TM
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Color Doppler US Artifact to Identify Localization of Breast and Axilla Tumor Markers
- ClinicalTrials.gov ID
- NCT06166173
- Acronym / sponsor ID
- BREAST TM
- Conditions
- Breast Cancer, Interventional Radiology, Doppler Ultrasound
- Keywords
- breast cancer, tumor marker, doppler ultrasound, neoadjuvan chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast tumor | – | –Female patients with breast tumors and/or axillary lymph node metastases who had markers placed before neoadjuvant chemotherapy (NACT), and patients undergoing preoperative marker localization after NACT |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with breast cancer and/or pathologically proven axillary lymph node involvement and who are planned or have received NACT
Key inclusion criteria (3 listed)
- patients who have breast cancer and will receive NACT,
- patients who are scheduled for breast-conserving surgery,
- those who are not allergic to metals
Key exclusion criteria (3 listed)
- patients with breast cancer for whom NACT is not planned,
- patients with bleeding disorders, patients with metallic allergies,
- patients with cooperation problems and those who cannot remain still during US
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Easier localization of breast tumor marker with Doppler ultrasound findings in approximately 20 patients
Time frame: through study completion, an average of 6 months
Use of Doppler US artifacts as an auxiliary diagnostic method in cases where tumor markers in the breast and axilla cannot be detected with conventional US.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Interventional Radiology, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Easier localization of breast tumor marker with Doppler ultrasound findings in approximately 20 patients (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.