Breast CancerCOMETNCT07106112
Carbon Suspension vs. Metallic Marker for Axillary Lymph Node Marking in Breast Cancer After Neoadjuvant Therapy
A study testing Ultrasound-guided carbon suspension (Black Eye) injection and Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement in people with Breast Cancer, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
This single-center, randomized study aims to compare the intraoperative detection rates of axillary lymph nodes marked with carbon suspension versus metallic markers in breast cancer patients (T1-3N1M0) before neoadjuvant therapy. Primary endpoint: frequency of marked lymph node identification during surgery. 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?
- Ultrasound-guided carbon suspension (Black Eye) injection and Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteRussia
- Study dates
- 15 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women ≥18 years.
- Morphologically confirmed breast cancer (T1-3N1M0).
- ECOG 0-1.
- Indication for neoadjuvant therapy.
- Signed informed consent.
Who cannot join
- No lymph node regression post-neoadjuvant therapy (persistent N1).
- Distant metastasis progression.
- Severe comorbidities (NYHA III-IV, COPD GOLD D, Child-Pugh C).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
St. Petersburg State University
Saint Petersburg
St. Petersburg State University, +7 (812) 363-60-00, spbu@spbu.ru
About this study
Official title: A Randomized Trial Comparing Carbon Suspension (Black Eye) and Metallic Markers (TWIRL ULTRACOR) for Localization of Metastatic Axillary Lymph Nodes Prior to Neoadjuvant Systemic Therapy in Breast Cancer Patients.
This single-center, randomized study aims to compare the intraoperative detection rates of axillary lymph nodes marked with carbon suspension versus metallic markers in breast cancer patients (T1-3N1M0) before neoadjuvant therapy. Primary endpoint: frequency of marked lymph node identification during surgery. Secondary endpoints: time from marking to surgery and quality of life (EORTC QLQ-BR23).
Read the detailed description
Interventions:
Group 1: Ultrasound-guided injection of 0.5 mL carbon suspension (Black Eye). Group 2: Ultrasound-guided placement of a metallic marker (TWIRL ULTRACOR). Follow-up: 6 months post-surgery. Design: Randomized 1:1, non-inferiority trial.
- Conditions
- Breast Cancer
- Being tested
- Ultrasound-guided carbon suspension (Black Eye) injection, Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement
- Keywords
- Carbon suspension, Axillary lymph node marking, Neoadjuvant therapy, Targeted axillary dissection, Metallic marker
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided carbon suspension (Black Eye) injectionProcedure or surgery
Under ultrasound guidance, 0.5 mL of sterile carbon particle suspension (Black Eye) is injected into the capsule of the metastatic axillary lymph node(s).
Technique: Performed using a high-frequency linear ultrasound probe (e.g., 12 MHz) and a 22G needle.
Target: Up to 3 pathologically confirmed metastatic lymph nodes. Timing: Performed before initiation of neoadjuvant systemic therapy (NST).
Rationale:
Carbon suspension provides long-term visual localization due to its black staining properties.
Inert and biocompatible, with minimal risk of allergic reactions. Patients proceed to standard NST based on tumor subtype (chemotherapy, targeted therapy, or endocrine therapy).
Post-NST imaging (ultrasound, CT, or PET-CT) to assess treatment response.
Surgical Intervention:
Targeted axillary dissection (TAD) with removal of marked nodes + sentinel lymph node biopsy (SLNB) using fluorescent dye.
Intraoperative frozen section analysis (hematoxylin \& eosin staining) of excised nodes.
Ultrasound-guided metallic marker (TWIRL ULTRACOR) placementProcedure or surgery
A 4-mm nitinol (nickel-titanium alloy) marker (TWIRL ULTRACOR) is deployed into the metastatic lymph node(s) under ultrasound guidance.
Technique: Uses a specialized introducer kit for precise placement. Target: Up to 3 pathologically confirmed metastatic lymph nodes. Timing: Performed before initiation of NST.
Rationale:
Nitinol markers are radiopaque, MRI-compatible, and resistant to migration. Standard method for tumor localization in breast cancer.
Post-Marking Protocol:
Identical NST and imaging follow-up as Group 1.
Surgical Intervention:
TAD with marker localization (palpation/imaging-guided excision) + SLNB. Intraoperative frozen section analysis.
| Study group | Role | What they receive |
|---|---|---|
| Carbon Suspension (Black Eye) Marking | Experimental | Not described Receives: Procedure: Ultrasound-guided carbon suspension (Black Eye) injection |
| Metallic Marker (TWIRL ULTRACOR) Placement | Active comparator | Not described Receives: Procedure: Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative detection rate of marked lymph nodes (%)
The proportion of successfully identified and excised marked lymph nodes during surgery, confirmed by visual (carbon suspension) or imaging/metallic detection (metallic marker)
Measured: Assessed intraoperatively (day of surgery).
Secondary outcomes (2)
Time from Marking to Surgery (Days)
Measures the duration (in days) between the lymph node marking procedure (carbon suspension or metallic seed placement) and the subsequent surgical intervention (targeted axillary dissection). This assesses the clinical feasibility and logistical timeline between marking and definitive treatment
Measured: From the date of marking procedure (Day 0) to the date of surgery (up to 12 weeks post-marking)
Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module [EORTC QLQ-BR23] Scores
Patient-reported outcomes assessed using the validated 23-item EORTC QLQ-BR23 questionnaire, which measures:
Functional scales (Body Image, Sexual Functioning, Sexual Enjoyment, Future Perspective; higher scores = better outcomes), Symptom scales (Systemic Therapy Side Effects, Breast Symptoms, Arm Symptoms, Upset by Hair Loss; higher scores = worse outcomes).
All items are scored 1-4 (raw scores) and transformed to a 0-100 scale. For functional scales, 100 represents optimal functioning; for symptom scales, 100 represents maximal symptom burden.
Measured: 1. Baseline (pre-marking), 2. Post-neoadjuvant therapy (pre-surgery) 3. 1-month postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start15 May 2025
- Primary completion15 May 2026 (estimated)
- Study completion31 Dec 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alina Olchonova, Saint Petersburg State University, Russia
- Investigators
- Alina A Olchonova, Physician, Principal investigator, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106112
- Sponsor's protocol ID
- 05/45
- Acronym
- COMET
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Carbon Suspension (Black Eye) and Metallic Markers (TWIRL ULTRACOR) for Localization of Metastatic Axillary Lymph Nodes Prior to Neoadjuvant Systemic Therapy in Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT07106112
- Acronym / sponsor ID
- COMET / 05/45
- Conditions
- Breast Cancer
- Keywords
- Carbon suspension, Axillary lymph node marking, Neoadjuvant therapy, Targeted axillary dissection, Metallic marker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Aug 2025 (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.
This single-center, randomized study aims to compare the intraoperative detection rates of axillary lymph nodes marked with carbon suspension versus metallic markers in breast cancer patients (T1-3N1M0) before neoadjuvant therapy. Primary endpoint: frequency of marked lymph node identification during surgery. Secondary endpoints: time from marking to surgery and quality of life (EORTC QLQ-BR23).
Detailed description
Interventions:
Group 1: Ultrasound-guided injection of 0.5 mL carbon suspension (Black Eye). Group 2: Ultrasound-guided placement of a metallic marker (TWIRL ULTRACOR). Follow-up: 6 months post-surgery. Design: Randomized 1:1, non-inferiority trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbon Suspension (Black Eye) Marking | Experimental | Procedure: Ultrasound-guided carbon suspension (Black Eye) injection |
| Metallic Marker (TWIRL ULTRACOR) Placement | Active comparator | Procedure: Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women ≥18 years.
- Morphologically confirmed breast cancer (T1-3N1M0).
- ECOG 0-1.
- Indication for neoadjuvant therapy.
- Signed informed consent.
Key exclusion criteria (3 listed)
- No lymph node regression post-neoadjuvant therapy (persistent N1).
- Distant metastasis progression.
- Severe comorbidities (NYHA III-IV, COPD GOLD D, Child-Pugh C).
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 |
|---|---|---|
| Ultrasound-guided carbon suspension (Black Eye) injectionUnder ultrasound guidance, 0.5 mL of sterile carbon particle suspension (Black Eye) is injected into the capsule of the metastatic axillary lymph node(s). Technique: Performed using a high-frequency linear ultrasound probe (e.g., 12 MHz) and a 22G needle. Target: Up to 3 pathologically confirmed metastatic lymph nodes. Timing: Performed before initiation of neoadjuvant systemic therapy (NST). Rationale: Carbon suspension provides long-term visual localization due to its black staining properties. Inert and biocompatible, with minimal risk of allergic reactions. Patients proceed to standard NST based on tumor subtype (chemotherapy, targeted therapy, or endocrine therapy). Post-NST imaging (ultrasound, CT, or PET-CT) to assess treatment response. Surgical Intervention: Targeted axillary dissection (TAD) with removal of marked nodes + sentinel lymph node biopsy (SLNB) using fluorescent dye. Intraoperative frozen section analysis (hematoxylin \& eosin staining) of excised nodes. | Procedure or surgery | Carbon Suspension (Black Eye) Marking |
| Ultrasound-guided metallic marker (TWIRL ULTRACOR) placementA 4-mm nitinol (nickel-titanium alloy) marker (TWIRL ULTRACOR) is deployed into the metastatic lymph node(s) under ultrasound guidance. Technique: Uses a specialized introducer kit for precise placement. Target: Up to 3 pathologically confirmed metastatic lymph nodes. Timing: Performed before initiation of NST. Rationale: Nitinol markers are radiopaque, MRI-compatible, and resistant to migration. Standard method for tumor localization in breast cancer. Post-Marking Protocol: Identical NST and imaging follow-up as Group 1. Surgical Intervention: TAD with marker localization (palpation/imaging-guided excision) + SLNB. Intraoperative frozen section analysis. | Procedure or surgery | Metallic Marker (TWIRL ULTRACOR) Placement |
Primary outcome
Intraoperative detection rate of marked lymph nodes (%)
Time frame: Assessed intraoperatively (day of surgery).
The proportion of successfully identified and excised marked lymph nodes during surgery, confirmed by visual (carbon suspension) or imaging/metallic detection (metallic marker)
2 secondary outcomes
Time from Marking to Surgery (Days)
Time frame: From the date of marking procedure (Day 0) to the date of surgery (up to 12 weeks post-marking)
Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module [EORTC QLQ-BR23] Scores
Time frame: 1. Baseline (pre-marking), 2. Post-neoadjuvant therapy (pre-surgery) 3. 1-month postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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.
Alina A Olchonova, Physician principal investigator
Saint Petersburg State University, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided carbon suspension (Black Eye) injection and Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement in people with Breast Cancer, run by Saint Petersburg State University, Russia at 1 site in Russia.
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 5 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: looking for participants now, as of the sponsor's last update on 6 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 Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alina A Olchonova, Physician (+79818197785, dr.lazakovich@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative detection rate of marked lymph nodes (%) (time frame: Assessed intraoperatively (day of surgery).). 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 6 Aug 2025.