Breast CancerNCT04274946
Sentinel Lymph Node Biopsy With Hybrid Technique in Breast Cancer
A study testing Sentinel lymph node biopsy in people with Breast Cancer, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Sentinel lymph node (SLN) biopsy is the gold standard method to stage axilla in breast cancer. The aim of the study is to compare the efficiency of various methods to identify SLN is breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jan 2025
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary breast cancer by core needle, incisional or excisional biopsy
- cN0 patients
- In patients with abnormal axillary lymph nodes sonographically US-guided FNA cytology of these nodes were performed and FNA cytology negative patients planed to undergo SLNB with different mapping techniques.
Who cannot join
- Patients with neoadjuvant therapy
- Patients with pathological diagnosed ductal carcinoma in situ by excisional biopsy
- Patients with pathologically proven axillary disease
- Patients with T4d tumor
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bülent Ecevit University
Zonguldak, 67600
guldeniz karadeniz cakmak, 05323371860, gkkaradeniz@yahoo.com
About this study
Official title: The Comparative Analysis of Multimodal Markers to Identify Sentinel Lymph Node in Breast Cancer
Sentinel lymph node (SLN) biopsy is the gold standard method to stage axilla in breast cancer. The aim of the study is to compare the efficiency of various methods to identify SLN is breast cancer patients.
Read the detailed description
Various markers has been used for SLN biopsy including isosulfan blue (patent blue), indocyanine green (ICG), radioisotope colloid (RAIC) and ultrasound (US) with several advantages and disadvantages. In this study investigators designed an algorithm using the combination of mapping with patent blue, ICG, RAIC and US to compare the accurate identification of SLN in breast cancer patients. The protocol is based on the hypothesis that identification rate of SLN is increased with multiple agents. Patent blue and ICG provides visual guidance. The combination of dyes with sonographic and RAIC method have the potential to prevent obstacles and ensure better outcomes as an identification strategy.
Patent blue provides visual identification of the SLN. ICG fluorescence can be detected percutaneously and by means of fluorescence imaging system in real time. RAI has several advantages, but disadvantages as well, like cost and invisibility. RAI can only be detected and confirmed by means of sound and numerical value through gamma probe. All breast cancer patients underwent axillary ultrasound before SLNB with different mapping combinations. The determination of abnormal axillary lymph node was followed by ultrasound-guided FNA cytology of these nodes. The sonographic abnormality criteria of the nodes were defined as; completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation more than 3, cortical thickness >2mm, totally spheric appearance, absence of fatty hilum and compromise of normal vascularity (hypervascularization from various poles). Patients with negative results of FNA would undergo SLNB. Lymphatic mapping was performed with abovementioned dyes and radioactive colloid. Before the incising for SLNB real time intraoperative US was performed and suspicious axillary lymph nodes were seen by ultrasound guidance. In the SLNB operation, radioactive or dyed nodes and sonographically suspicious nodes were removed and labeled separately for pathological examination.
- Conditions
- Breast Cancer
- Being tested
- Sentinel lymph node biopsy
- Keywords
- breast, sentinel lymph node, patent blue, indocyanine green
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph node biopsyProcedure or surgery
Sentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| RAI+PB+US | Active comparator | Sentinel lymph node mapping with dual tracer (radioisotope and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients Receives: Procedure: Sentinel lymph node biopsy |
| RAI+ICG+US | Experimental | Sentinel lymph node mapping with dual tracer (radioisotope and ICG) and intraoperative ultrasound to identify SLN in the breast cancer patients Receives: Procedure: Sentinel lymph node biopsy |
| RAI+PB+ICG+US | Experimental | Sentinel lymph node mapping with triple tracer (radioisotope,ICG and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients Receives: Procedure: Sentinel lymph node biopsy |
| PB+ICG+US | Experimental | Sentinel lymph node mapping with triple tracer (ICG and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients Receives: Procedure: Sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification rate of sentinel lymph node
The ability to identify a sentinel lymph node successfully with different mapping techniques
Measured: During operation
Secondary outcomes (3)
Average number of excised sentinel lymph nodes
The effect of mapping technique on the number of excised nodes
Measured: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
False-negative rate of axillary US
False negative rate for SLN surgery in women with normal or axillary US and at least 2 SLNs were excised, defined as the number of patients with no positive lymph nodes by SLN and with at least one positive lymph node by axillary lymph node dissection divided by the total number of patients with at least one positive lymph node by SLN or ALND multiplied by 100, or vise versa. For abnormal axillary US, false negative rate is calculated similarly.
Measured: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
Morbidity
Lymphedema, shoulder movement pain, or functional deformity after SLNB with different mapping techniques will be assessed by clinicians during follow-up with 3 months periods. The result will be the percentage of patients which suffer from some complications after SLNB or AD. Common morbidity rate after AD is 20%, after SLNB 1-2%.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2025 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-center, randomized study.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guldeniz Karadeniz Cakmak, Bulent Ecevit University
- Investigators
- Güldeniz Karadeniz Cakmak, MD, Study chair, Bülent Ecevit University Department of SurgeryRabiye Uslu Erdemir, MD, Study director, Bülent Ecevit University Department of Nucleer MedicineHakan Bakkal, MD, Principal investigator, Bülent Ecevit University Department of Radiation OncologyHüseyin Engin, MD, Principal investigator, Bülent Ecevit University Department of Clinical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274946
- Sponsor's protocol ID
- 2019-09-09
- Status last verified
- Feb 2020
- First submitted
- 16 Feb 2020
- Last updated
- 19 Feb 2020
- 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 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Analysis of Multimodal Markers to Identify Sentinel Lymph Node in Breast Cancer
- ClinicalTrials.gov ID
- NCT04274946
- Acronym / sponsor ID
- 2019-09-09
- Conditions
- Breast Cancer
- Keywords
- breast, sentinel lymph node, patent blue, indocyanine green
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 18 Feb 2020 (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.
Sentinel lymph node (SLN) biopsy is the gold standard method to stage axilla in breast cancer. The aim of the study is to compare the efficiency of various methods to identify SLN is breast cancer patients.
Detailed description
Various markers has been used for SLN biopsy including isosulfan blue (patent blue), indocyanine green (ICG), radioisotope colloid (RAIC) and ultrasound (US) with several advantages and disadvantages. In this study investigators designed an algorithm using the combination of mapping with patent blue, ICG, RAIC and US to compare the accurate identification of SLN in breast cancer patients. The protocol is based on the hypothesis that identification rate of SLN is increased with multiple agents. Patent blue and ICG provides visual guidance. The combination of dyes with sonographic and RAIC method have the potential to prevent obstacles and ensure better outcomes as an identification strategy.
Patent blue provides visual identification of the SLN. ICG fluorescence can be detected percutaneously and by means of fluorescence imaging system in real time. RAI has several advantages, but disadvantages as well, like cost and invisibility. RAI can only be detected and confirmed by means of sound and numerical value through gamma probe. All breast cancer patients underwent axillary ultrasound before SLNB with different mapping combinations. The determination of abnormal axillary lymph node was followed by ultrasound-guided FNA cytology of these nodes. The sonographic abnormality criteria of the nodes were defined as; completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation more than 3, cortical thickness >2mm, totally spheric appearance, absence of fatty hilum and compromise of normal vascularity (hypervascularization from various poles). Patients with negative results of FNA would undergo SLNB. Lymphatic mapping was performed with abovementioned dyes and radioactive colloid. Before the incising for SLNB real time intraoperative US was performed and suspicious axillary lymph nodes were seen by ultrasound guidance. In the SLNB operation, radioactive or dyed nodes and sonographically suspicious nodes were removed and labeled separately for pathological examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective, single-center, randomized study.
| Arm | Type | Receives |
|---|---|---|
| RAI+PB+US | Active comparator | Procedure: Sentinel lymph node biopsySentinel lymph node mapping with dual tracer (radioisotope and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients |
| RAI+ICG+US | Experimental | Procedure: Sentinel lymph node biopsySentinel lymph node mapping with dual tracer (radioisotope and ICG) and intraoperative ultrasound to identify SLN in the breast cancer patients |
| RAI+PB+ICG+US | Experimental | Procedure: Sentinel lymph node biopsySentinel lymph node mapping with triple tracer (radioisotope,ICG and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients |
| PB+ICG+US | Experimental | Procedure: Sentinel lymph node biopsySentinel lymph node mapping with triple tracer (ICG and patent blue) and intraoperative ultrasound to identify SLN in the breast cancer patients |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed primary breast cancer by core needle, incisional or excisional biopsy
- cN0 patients
- In patients with abnormal axillary lymph nodes sonographically US-guided FNA cytology of these nodes were performed and FNA cytology negative patients planed to undergo SLNB with different mapping techniques.
Key exclusion criteria (4 listed)
- Patients with neoadjuvant therapy
- Patients with pathological diagnosed ductal carcinoma in situ by excisional biopsy
- Patients with pathologically proven axillary disease
- Patients with T4d tumor
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 |
|---|---|---|
| Sentinel lymph node biopsySentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound. | Procedure or surgery | PB+ICG+US, RAI+ICG+US, RAI+PB+ICG+US, RAI+PB+US |
Primary outcome
Identification rate of sentinel lymph node
Time frame: During operation
The ability to identify a sentinel lymph node successfully with different mapping techniques
3 secondary outcomes
Average number of excised sentinel lymph nodes
Time frame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
False-negative rate of axillary US
Time frame: Histological report expected within an average of 2 weeks after sentinel lymph node biopsy
Morbidity
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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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.
Güldeniz Karadeniz Cakmak, MD study chair
Bülent Ecevit University Department of Surgery
Rabiye Uslu Erdemir, MD study director
Bülent Ecevit University Department of Nucleer Medicine
Hakan Bakkal, MD principal investigator
Bülent Ecevit University Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel lymph node biopsy in people with Breast Cancer, run by Bulent Ecevit 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 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: status not confirmed, as of the sponsor's last update on 19 Feb 2020. 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?
Contact Guldeniz Karadeniz Cakmak, MD (05323371860, gkkaradeniz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification rate of sentinel lymph node (time frame: During operation). 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 19 Feb 2020.