Breast CancerNCT05735795
Feasibility of Carbon-Dye Marking of Axillary Lymph Nodes Before Neoadjuvant Chemotherapy in Patients With Breast Cancer
A study testing Carbon Black Tattoo in people with Breast Cancer, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although treatment is started with surgery in early stage tumors depending on the molecular subtype, neoadjuvant chemotherapy is the initial treatment in locally advanced tumors or if axillary lymph node involvement is present. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Carbon Black Tattoo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2023to 25 Sep 2024
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with locally advanced breast cancer known to have metastases to the axillary lymph nodes at baseline and referred for neoadjuvant chemotherapy will be included in the study.
Who cannot join
- diagnosis by excisional biopsy
- previous axillary surgery
- failure to complete neoadjuvant therapy
- progression during therapy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul, 34000
About this study
Official title: Feasibility of Carbon Dye Marking of Axillary Lymph Nodes Before Neoadjuvant Chemotherapy in Patients With Breast Cancer
Although treatment is started with surgery in early stage tumors depending on the molecular subtype, neoadjuvant chemotherapy is the initial treatment in locally advanced tumors or if axillary lymph node involvement is present.
Axillary lymph node dissection (ALND) has been used for a very long time in the traditional approach to the treatment of breast cancer. The current approach in patients with early stage, clinically negative breast cancer of the axilla is sentinel lymph node biopsy (SLNB). SLNB is done to evaluate the axilla in both early stage tumors and suitable patients after NAC. According to ACOSOG Z1071, when at least 3 lymph nodes were removed using lymphoscintigraphy and blue dye for SLNB, the false-negative rate was found to be less than 10% in patients with proven axillary involvement, and SLNB was shown to be feasible after NAC. Targeted axillary dissection (TAD) is a procedure that includes SLND with removal of the lymph node identified and marked as containing metastatic disease before treatment. Multiple clinical studies have shown that TAD is a viable option to reduce false-negativeness in patients with breast cancer after NAC. In patients with axillary involvement, a metallic clip is placed in the suspected lymph node prior to neoadjuvant therapy and a radioactive iodine-125 seed is implanted into the target after completion of chemotherapy, and during TAD, the core node is removed using a radioactive probe. Today, the applicability of these procedures is difficult due to both the cost and the absence of nuclear medicine units in some hospitals. For this reason, alternative methods that can be applied more easily in the evaluation of the axilla after NAC are being investigated. SPOT ENDOSCOPIC MARKER is an FDA (American Food and Drug Administration) approved Carbon Black Tattoo paint that has been used for a long time to mark lesions in the gastrointestinal tract. Its shelf life is 20 months. In our project, in patients with lymph node involvement in the axilla who have had a metallic clip placed with biopsy before NAC, the lymph node will be marked with a Spot Endoscopic Marker simultaneously, and the permanence of the spot marker dye will be evaluated by excising the clip-marked and black-painted lymph node in addition to the methylen blue injected during the operation. The reliability of the use of Spot Endoscopic Marker, which is much cheaper instead of clips, for permanent axillary marking in TAD will be evaluated.
Read the detailed description
Breast cancer affects millions of women worldwide. According to the statistics, 2.3 million new cases of breast cancer were reported in 2020. Although treatment is started with surgery in early stage tumors depending on the molecular subtype, neoadjuvant chemotherapy is the initial treatment in locally advanced tumors or if axillary lymph node involvement is present. With NAC in locally advanced breast cancer, it is possible to both shrink the tumor and make patients who were initially inoperable suitable for surgery, and increase the feasibility of breast-conserving surgery.
Although axillary lymph node dissection (ALND) has been used for a very long time in the traditional approach to the treatment of breast cancer, the current approach in patients with early stage, clinically negative breast cancer of the axilla is sentinel lymph node biopsy (SLNB). SLNB is done to evaluate the axilla in both early stage tumors and suitable patients after NAC. According to ACOSOG Z1071, when at least 3 lymph nodes were removed using lymphoscintigraphy and blue dye for SLNB, the false-negative rate was found to be less than 10% in patients with proven axillary involvement, and SLNB was shown to be feasible after NAC. Targeted axillary dissection (TAD) is a procedure that includes SLND with removal of the lymph node identified and marked as containing metastatic disease before treatment. Multiple clinical studies have shown that TAD is a viable option to reduce false-negativeness in patients with breast cancer after NAC. In patients with axillary involvement, a metallic clip is placed in the suspected lymph node prior to neoadjuvant therapy and a radioactive iodine-125 seed is implanted into the target after completion of chemotherapy, and during TAD, the core node is removed using a radioactive probe. The procedure is performed with SLND using the dual-tracer technique. Today, the applicability of these procedures is difficult due to both the cost and the absence of nuclear medicine units in some hospitals. For this reason, alternative methods that can be applied more easily in the evaluation of the axilla after NAC are being investigated. SPOT ENDOSCOPIC MARKER is an FDA (American Food and Drug Administration) approved Carbon Black Tattoo paint that has been used for a long time to mark lesions in the gastrointestinal tract. Its shelf life is 20 months. In our project, in patients with lymph node involvement in the axilla who have had a metallic clip placed with biopsy before NAC, the lymph node will be marked with a Spot Endoscopic Marker simultaneously, and the permanence of the spot marker dye will be evaluated by excising the clip-marked and black-painted lymph node in addition to the methylen blue injected during the operation. The reliability of the use of Spot Endoscopic Marker, which is much cheaper instead of clips, for permanent axillary marking in TAD will be evaluated.
- Conditions
- Breast Cancer
- Being tested
- Carbon Black Tattoo
- Keywords
- breast cancer, Lymph node metastasis, Targeted axillary dissection, Nodal marking
- Medical subject headings
- Breast Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Black TattooOther
SPOT ENDOSCOPIC MARKER is an FDA (American Food and Drug Administration) approved Carbon Black Tattoo paint that has been used for a long time to mark lesions in the gastrointestinal tract.
| Study group | Role | What they receive |
|---|---|---|
| Carbon Black Tattoo arm | Other | In patients with breast cancer diagnosed with positive axillary lymph node involvement by fine needle aspiration cytology, 0.1-0.5 ml Carbon Black Tattoo dye will be applied simultaneously to the lymph node capsule and surrounding tissue, while clips are placed on the axilla before starting neoadjuvant chemotherapy. After the neoadjuvant treatment is completed, the patient who is taken into surgery will be injected with periareolar blue dye as in the standard practice, and blue stained node, clipped node and carbon stained node will be searched as sentinal lymph node. The removed lymph nodes will be evaluated histopathologically in terms of metastasis with a frozen study during the operation, and if metastasis is detected, axillary lymph node dissection will be performed Receives: Other: Carbon Black Tattoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reliability of the use of Spot Endoscopic Marker
Carbon tattoo is an FDA-approved dye that is used to mark lesions in the gastrointestinal tract in vivo. It is used in lesion follow-up because it is permanent for a long time. In current practice, lymph nodes with biopsy-proven axillary lymph node involvement before neoadjuvant chemotherapy are marked with a metallic clip before starting the treatment and excised as sentinal lymph node during surgery. This procedure is both expensive and difficult to implement due to the necessity of having a nuclear medicine department in the hospital. Our aim in this study is to evaluate the excision of the lymph node by marking it with carbon dye instead of a clip.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start7 Feb 2023
- Primary completion15 Sep 2024
- Study completion25 Sep 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emine Yıldırım, Gaziosmanpasa Research and Education Hospital
- Investigators
- Emine Yildirim, Assoc. Prof., Principal investigator, Gaziosmanpasa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735795
- Sponsor's protocol ID
- 2023-09
- Status last verified
- Aug 2025
- First submitted
- 8 Feb 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Carbon Dye Marking of Axillary Lymph Nodes Before Neoadjuvant Chemotherapy in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT05735795
- Acronym / sponsor ID
- 2023-09
- Conditions
- Breast Cancer
- Keywords
- breast cancer, Lymph node metastasis, Targeted axillary dissection, Nodal marking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 21 Feb 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.
Although treatment is started with surgery in early stage tumors depending on the molecular subtype, neoadjuvant chemotherapy is the initial treatment in locally advanced tumors or if axillary lymph node involvement is present.
Axillary lymph node dissection (ALND) has been used for a very long time in the traditional approach to the treatment of breast cancer. The current approach in patients with early stage, clinically negative breast cancer of the axilla is sentinel lymph node biopsy (SLNB). SLNB is done to evaluate the axilla in both early stage tumors and suitable patients after NAC. According to ACOSOG Z1071, when at least 3 lymph nodes were removed using lymphoscintigraphy and blue dye for SLNB, the false-negative rate was found to be less than 10% in patients with proven axillary involvement, and SLNB was shown to be feasible after NAC. Targeted axillary dissection (TAD) is a procedure that includes SLND with removal of the lymph node identified and marked as containing metastatic disease before treatment. Multiple clinical studies have shown that TAD is a viable option to reduce false-negativeness in patients with breast cancer after NAC. In patients with axillary involvement, a metallic clip is placed in the suspected lymph node prior to neoadjuvant therapy and a radioactive iodine-125 seed is implanted into the target after completion of chemotherapy, and during TAD, the core node is removed using a radioactive probe. Today, the applicability of these procedures is difficult due to both the cost and the absence of nuclear medicine units in some hospitals. For this reason, alternative methods that can be applied more easily in the evaluation of the axilla after NAC are being investigated. SPOT ENDOSCOPIC MARKER is an FDA (American Food and Drug Administration) approved Carbon Black Tattoo paint that has been used for a long time to mark lesions in the gastrointestinal tract. Its shelf life is 20 months. In our project, in patients with lymph node involvement in the axilla who have had a metallic clip placed with biopsy before NAC, the lymph node will be marked with a Spot Endoscopic Marker simultaneously, and the permanence of the spot marker dye will be evaluated by excising the clip-marked and black-painted lymph node in addition to the methylen blue injected during the operation. The reliability of the use of Spot Endoscopic Marker, which is much cheaper instead of clips, for permanent axillary marking in TAD will be evaluated.
Detailed description
Breast cancer affects millions of women worldwide. According to the statistics, 2.3 million new cases of breast cancer were reported in 2020. Although treatment is started with surgery in early stage tumors depending on the molecular subtype, neoadjuvant chemotherapy is the initial treatment in locally advanced tumors or if axillary lymph node involvement is present. With NAC in locally advanced breast cancer, it is possible to both shrink the tumor and make patients who were initially inoperable suitable for surgery, and increase the feasibility of breast-conserving surgery.
Although axillary lymph node dissection (ALND) has been used for a very long time in the traditional approach to the treatment of breast cancer, the current approach in patients with early stage, clinically negative breast cancer of the axilla is sentinel lymph node biopsy (SLNB). SLNB is done to evaluate the axilla in both early stage tumors and suitable patients after NAC. According to ACOSOG Z1071, when at least 3 lymph nodes were removed using lymphoscintigraphy and blue dye for SLNB, the false-negative rate was found to be less than 10% in patients with proven axillary involvement, and SLNB was shown to be feasible after NAC. Targeted axillary dissection (TAD) is a procedure that includes SLND with removal of the lymph node identified and marked as containing metastatic disease before treatment. Multiple clinical studies have shown that TAD is a viable option to reduce false-negativeness in patients with breast cancer after NAC. In patients with axillary involvement, a metallic clip is placed in the suspected lymph node prior to neoadjuvant therapy and a radioactive iodine-125 seed is implanted into the target after completion of chemotherapy, and during TAD, the core node is removed using a radioactive probe. The procedure is performed with SLND using the dual-tracer technique. Today, the applicability of these procedures is difficult due to both the cost and the absence of nuclear medicine units in some hospitals. For this reason, alternative methods that can be applied more easily in the evaluation of the axilla after NAC are being investigated. SPOT ENDOSCOPIC MARKER is an FDA (American Food and Drug Administration) approved Carbon Black Tattoo paint that has been used for a long time to mark lesions in the gastrointestinal tract. Its shelf life is 20 months. In our project, in patients with lymph node involvement in the axilla who have had a metallic clip placed with biopsy before NAC, the lymph node will be marked with a Spot Endoscopic Marker simultaneously, and the permanence of the spot marker dye will be evaluated by excising the clip-marked and black-painted lymph node in addition to the methylen blue injected during the operation. The reliability of the use of Spot Endoscopic Marker, which is much cheaper instead of clips, for permanent axillary marking in TAD will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Carbon Black Tattoo arm | Other | Other: Carbon Black TattooIn patients with breast cancer diagnosed with positive axillary lymph node involvement by fine needle aspiration cytology, 0.1-0.5 ml Carbon Black Tattoo dye will be applied simultaneously to the lymph node capsule and surrounding tissue, while clips are placed on the axilla before starting neoadjuvant chemotherapy. After the neoadjuvant treatment is completed, the patient who is taken into surgery will be injected with periareolar blue dye as in the standard practice, and blue stained node, clipped node and carbon stained node will be searched as sentinal lymph node. The removed lymph nodes will be evaluated histopathologically in terms of metastasis with a frozen study during the operation, and if metastasis is detected, axillary lymph node dissection will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with locally advanced breast cancer known to have metastases to the axillary lymph nodes at baseline and referred for neoadjuvant chemotherapy will be included in the study.
Key exclusion criteria (4 listed)
- diagnosis by excisional biopsy
- previous axillary surgery
- failure to complete neoadjuvant therapy
- progression during therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Black TattooSPOT ENDOSCOPIC MARKER is an FDA (American Food and Drug Administration) approved Carbon Black Tattoo paint that has been used for a long time to mark lesions in the gastrointestinal tract. | Other | Carbon Black Tattoo arm |
Primary outcome
The reliability of the use of Spot Endoscopic Marker
Time frame: 12 months
Carbon tattoo is an FDA-approved dye that is used to mark lesions in the gastrointestinal tract in vivo. It is used in lesion follow-up because it is permanent for a long time. In current practice, lymph nodes with biopsy-proven axillary lymph node involvement before neoadjuvant chemotherapy are marked with a metallic clip before starting the treatment and excised as sentinal lymph node during surgery. This procedure is both expensive and difficult to implement due to the necessity of having a nuclear medicine department in the hospital. Our aim in this study is to evaluate the excision of the lymph node by marking it with carbon dye instead of a clip.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
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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.
Emine Yildirim, Assoc. Prof. principal investigator
Gaziosmanpasa Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Black Tattoo in people with Breast Cancer, run by Gaziosmanpasa Research and Education Hospital 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 24 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The reliability of the use of Spot Endoscopic Marker (time frame: 12 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 24 Aug 2025.