Breast CancerINIGMANCT07362485
Finding Sentinel Lymph Nodes During Mastectomy Using Indocyanine Green (INIGMA Study)
A study testing Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy in people with Breast Cancer and Sentinel Lymph Node Biopsy (SLNB), run by Isabelle Henskens at 2 sites in Netherlands.
Trial summary
This pilot study evaluates the diagnostic value of indocyanine green (ICG) fluorescence for sentinel lymph node biopsy (SLNB) performed through the mastectomy incision in breast cancer patients. Women with clinically node-negative, invasive T1-T3 breast cancer undergoing mastectomy with SLNB at St. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node Biopsy (SLNB), Sentinel Lymph Node Detection
- What is being tested?
- Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesNetherlands
- Study dates
- 22 Aug 2022to Jun 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
- Clinically node-negative, DCIS, invasive T1- T3 breast cancer confirmed by biopsy.
- Preoperative axillary ultrasound to confirm clinical node-negative status.
- Indication (or preference) for mastectomy and simultaneous SLN procedure.
- Written informed consent according to ICH/GCP and national regulations.
Who cannot join
- Patients < 18 years old
- Breast conserving surgery
- Direct reconstruction (with autologous tissue or implant)
- Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc), intravenous contrast or iodine
- Other concurrent solid tumour
- Hyperthyroidism or thyroid cancer
- Pregnancy or breast feeding
- Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
St. Antonius Ziekenhuis
Utrecht, Utrecht, 3543 AZ
Isabelle Henskens, MD, +31883202902, i.henskens@antoniusziekenhuis.nl
Annemiek Doeksen, MD, PhD, +3183202900, a.doeksen@antoniusziekenhuis.nl
- Recruiting
Isala
Zwolle, Overijssel, 8025 AB
Maarten Beek, MD, PhD, +3188 624 50 00, m.a.beek@isala.nl
About this study
Official title: Indocyanine Green Guided Identification of Sentinel Lymph Nodes Via Mastectomy Incision in Breast Cancer Patients (INIGMA Study)
This pilot study evaluates the diagnostic value of indocyanine green (ICG) fluorescence for sentinel lymph node biopsy (SLNB) performed through the mastectomy incision in breast cancer patients.
Women with clinically node-negative, invasive T1-T3 breast cancer undergoing mastectomy with SLNB at St. Antonius or Isala Hospital will be included. All patients receive standard 99mTc injection preoperatively, followed by 5 mg (2mL) ICG injection after anesthesia. The axilla will be explored for fluorescent lymph nodes via the mastectomy incision, avoiding a separate axillary incision.
Read more
Primary outcome: ICG detection rate for SLN identification via the mastectomy incision.
Secondary outcomes: Comparison with 99mTc detection, number of nodes identified, concordance between methods, pathology differences, detection time, and complications.
ICG is safe, non-ionizing, and causes no extra discomfort or visits. Risks and burden are minimal.
Read the detailed description
Background:
Identifying lymphatic metastases is an important prognostic factor in the survival rate of breast cancer and the presence of lymphatic metastases carries consequences for further treatment. Results the non-inferiority INFLUENCE study and previous literature, led to the implementation of ICG-guided SLNBs via axillary incision as standard of care at the St. Antonius Hospital. The diagnostic performance of ICG-fluorescence for SNLBs using the mastectomy incision has not been described yet. Surgeons may perform SLNBs using the same incision as the mastectomy, rather than using an additional axillary incision. In such setting, extended operating distance and visualization with an improper angle might introduce challenges to identify the SLN by tracking lymphatic vessels into the axilla.
Objective:
This pilot study aims to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLNBs via the mastectomy incision.
Study design:
This is a multicenter, cross-sectional pilot study identifying the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLN mapping via the mastectomy incision (different surgical approach).
Study population:
Women with breast cancer who are admitted to the St. Antonius Hospital or Isala Hospital. Inclusion criteria include clinically nodenegative, invasive T1-T3 breast cancer conformed by biopsy, preoperative axillary ultrasound to confirm clinical node-negative status and indication for mastectomy with SLN procedure.
Intervention:
All included patients will receive standard of care implying 99mTc injection the day before surgery. Consequently, 5 mg (2 ml) ICG will be injected periareolar after administration of general anaesthesia and before incision. The lateral edge of the standard mastectomy incision will be used to explore the axilla for ICG fluorescent lymph nodes to avoid a separate axillary incision. Then the excised nodes are tested for 99mTc activity with the standard gamma detecting probe as control. Lastly, the axilla will be explored with the standard gamma-probe for residual lymph nodes, and by common sight and palpation as a control.
Outcomes:
Primary: to assess the detection rate of the ICG method to identify the SLN via a mastectomy incision.
Secondary:
- The detection rate of 99mTc
- The difference in detection rate between ICG and 99mTc
- The median number of SLN identified with ICG and the standard 99mTc
- Percentage of SLNs that is fluorescent, but not positive for 99mTc
- Percentage of SLNs that are not fluorescent but positive for 99mTc
- The difference in pathology of the SLN found by ICG and 99mTc, including the difference between micro- and macro metastases (Mic and Mac resp.) and isolated tumor cells (ITCs)
- Detection time for the use of ICG to detect the SLN, defined as time between skin incision and SLN resection in minutes
- Complications, including wound infection, bleeding and lymphedema, of the combination of the ICG method and the standard 99mTc method to identify the SLN in mastectomies
- The number of serious adverse events from the combination of ICG and 99mTc
Risks and burden:
Consenting patients will not need to do anything extra than the standard of care outside signing the informed consent. Administration of ICG will be done while under general anaesthesia, so patients will not experience extra discomfort, neither do they need extra site visits as the follow-up will be done during the standard follow-up appointment. ICG is safe to use: it is nonionizing and knows little to no complications and adverse events. Considering the cut-off of 2 additional nodes, the preferable topographic location of these nodes and the clinical experience with additional lymph node sampling, no increase in risk of surgical morbidity is expected. Patients might benefit from the intervention as ICG can increase the identification rate of the sentinel lymph node procedure and might even replace 99mTc for SLN mapping. Thus, both risks and burden are minimal.
- Conditions
- Breast Cancer, Sentinel Lymph Node Biopsy (SLNB), Sentinel Lymph Node Detection, Sentinel Lymph Node, Lymphatic Metastasis, Fluorescence Imaging
- Being tested
- Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy
- Keywords
- Breast cancer, Sentinel lymph node biopsy, Indocyanine green, Mastectomy, Fluorescence imaging, Lymph node mapping, Surgical oncology, Techetium nanocolloïd, Radioisotope
- 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.
Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsyOther
ICG-fluorescence is used as the primary tracer to identify SLNs during SLNB in breast cancer surgery. The standard 99mTc-nanocolloid method is used as a control to verify the sentinel lymph nodes identified by ICG. Surgeons are blinded to preoperative lymphoscintigraphy results. After general anesthesia, 5 mg (2 mL of 2.5 mg/mL solutio) of ICG is injected sub-/intracutaneous periareolarly. ICG-fluorescence is detected using near-infrared imaging. SLNB via mastectomy incision is performed. The most fluorescent lymph node is excised first, followed by (maximal 2) additional fluorescent nodes. The excised nodes are tested for 99mTc-activity using a gamma probe. The axilla is then checked with the gamma probe and and palpation for any remaining nodes, which are excised if their radiation count exceeds 10% of the hottest node. All excised lymph nodes are sent for pathological examination to determine the presence of cancer cells. After surgery, the lymphoscintigraphy results are announced.
| Study group | Role | What they receive |
|---|---|---|
| ICG-fluorescence imaging with 99mTc control for SLNB | Experimental | This experimental arm involves participants receiving indocyanine green (ICG) fluorescence imaging as the primary method for sentinel lymph node biopsy (SLNB), with 99mTc-nanocolloid serving as the within-patient control. Both methods are applied during the same surgical procedure. This design allows each participant to serve as their own control for comparing the diagnostic perfomance of both techniques directly in indentifying sentinel lymph nodes via mastectomy incision. Receives: Other: Indocyanine green (ICG)-fluorescence guided 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 nodes using indocyanine green fluorescence
The identification rate is defined as the proportion of participants in whom at least one sentinel lymph node (SLN) is successfully identified using indocyanine green (ICG) fluorescence imaging via the mastectomy incision during surgery.
Measured: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Secondary outcomes (10)
Identification rate of sentinel lymph nodes using 99mTc
The identification rate is defined as the proportion of participants in whom at least one sentinel lymph node is identified using the standard-of-care radioisotope technetium-99m (99mTc) during the same surgical procedure.
Measured: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Difference in sentinel lymph node detection rate between ICG and 99mTc
The absolute difference in identification rates between indocyanine green (ICG) fluorescence imaging and technetium-99m (99mTc) for sentinel lymph node detection within the same participant.
Measured: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Number of sentinel lymph nodes identified per participant by ICG and 99mTc
The total number of sentinel lymph nodes identified per participant using indocyanine green (ICG) fluorescence imaging and using technetium-99m (99mTc) during surgery.
Measured: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Proportion of participants with fluorescent sentinel lymph nodes among those identified by 99mTc
The percentage of participants in whom sentinel lymph nodes identified by the standard-of-care technetium-99m (99mTc) are also fluorescent when assessed with indocyanine green (ICG).
Measured: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Fluorescent sentinel lymph nodes not positive for 99mTc
The percentage of sentinel lymph nodes that demonstrate fluorescence with indocyanine green (ICG) but show no detectable activity on technetium-99m (99mTc) assessment.
Measured: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Sentinel lymph nodes positive for 99mTc but not fluorescent
The percentage of sentinel lymph nodes that are positive for technetium-99m (99mTc) activity but do not demonstrate fluorescence with indocyanine green (ICG).
Measured: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Pathological status of sentinel lymph nodes identified by ICG and 99mTc
Pathological assessment of sentinel lymph nodes identified by indocyanine green (ICG) and technetium-99m (99mTc), including the presence of isolated tumour cells, micrometastases, or macrometastases.
Measured: From surgical resection of sentinel lymph nodes until completion of histopathological assessment, assessed within approximately 3 weeks after surgery
Detection time for sentinel lymph node identification using ICG
Detection time is defined as the time in minutes between skin incision and resection of the first sentinel lymph node identified using indocyanine green (ICG) fluorescence imaging.
Measured: During the surgical procedure (from skin incision to sentinel lymph node resection)
Procedure-related complications associated with ICG and 99mTc
The proportion of participants experiencing complications related to the sentinel lymph node procedure using indocyanine green (ICG) and technetium-99m (99mTc), including seroma requiring drainage, wound infection requiring antibiotic or surgical treatment, bleeding requiring reoperation, and mild allergic reactions.
Measured: From surgery up to 2 months postoperatively
Serious adverse events related to ICG and 99mTc
The number of participants experiencing serious adverse events related to indocyanine green (ICG) or technetium-99m (99mTc), including severe allergic reactions, death, or other serious adverse events.
Measured: From surgery up to 2 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start22 Aug 2022
- Primary completionApr 2026 (estimated)
- Study completionJun 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive both indocyanine green (ICG) fluorescence imaging and standard 99mTc-nanocolloid sentinel lymph node mapping during the same surgical procedure. The procedure is primarily performed using ICG fluorescence imaging, with 99mTc serving as the control method to assess the diagnostic performance of ICG compared to 99mTc. Each patient serves as her own control in this within-subject comparison.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isabelle Henskens
- Sponsor type
- University, hospital or other
- Collaborators
- Isala
- Responsible party
- Sponsor-investigator, Isabelle Henskens, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362485
- Sponsor's protocol ID
- NL80591.100.22
- Acronym
- INIGMA
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At present, there is no final decision regarding sharing of individual participant data (IPD). Data sharing will depend on ethical approval, participant consent, and compliance with applicable privacy regulations. If IPD sharing is pursued, only de-identified datasets relevant to the research question will be made available upon reasonable request to qualified researchers, under a data use agreement ensuring confidentiality and scientific integrity
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine Green Guided Identification of Sentinel Lymph Nodes Via Mastectomy Incision in Breast Cancer Patients (INIGMA Study)
- ClinicalTrials.gov ID
- NCT07362485
- Acronym / sponsor ID
- INIGMA / NL80591.100.22
- Conditions
- Breast Cancer, Sentinel Lymph Node Biopsy (SLNB), Sentinel Lymph Node Detection, Sentinel Lymph Node, Lymphatic Metastasis, Fluorescence Imaging
- Keywords
- Breast cancer, Sentinel lymph node biopsy, Indocyanine green, Mastectomy, Fluorescence imaging, Lymph node mapping, Surgical oncology, Techetium nanocolloïd
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Isabelle HenskensUniversity, hospital or other
- Collaborators
- Isala
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 Jan 2026 (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 pilot study evaluates the diagnostic value of indocyanine green (ICG) fluorescence for sentinel lymph node biopsy (SLNB) performed through the mastectomy incision in breast cancer patients.
Women with clinically node-negative, invasive T1-T3 breast cancer undergoing mastectomy with SLNB at St. Antonius or Isala Hospital will be included. All patients receive standard 99mTc injection preoperatively, followed by 5 mg (2mL) ICG injection after anesthesia. The axilla will be explored for fluorescent lymph nodes via the mastectomy incision, avoiding a separate axillary incision.
Primary outcome: ICG detection rate for SLN identification via the mastectomy incision.
Secondary outcomes: Comparison with 99mTc detection, number of nodes identified, concordance between methods, pathology differences, detection time, and complications.
ICG is safe, non-ionizing, and causes no extra discomfort or visits. Risks and burden are minimal.
Detailed description
Background:
Identifying lymphatic metastases is an important prognostic factor in the survival rate of breast cancer and the presence of lymphatic metastases carries consequences for further treatment. Results the non-inferiority INFLUENCE study and previous literature, led to the implementation of ICG-guided SLNBs via axillary incision as standard of care at the St. Antonius Hospital. The diagnostic performance of ICG-fluorescence for SNLBs using the mastectomy incision has not been described yet. Surgeons may perform SLNBs using the same incision as the mastectomy, rather than using an additional axillary incision. In such setting, extended operating distance and visualization with an improper angle might introduce challenges to identify the SLN by tracking lymphatic vessels into the axilla.
Objective:
This pilot study aims to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLNBs via the mastectomy incision.
Study design:
This is a multicenter, cross-sectional pilot study identifying the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLN mapping via the mastectomy incision (different surgical approach).
Study population:
Women with breast cancer who are admitted to the St. Antonius Hospital or Isala Hospital. Inclusion criteria include clinically nodenegative, invasive T1-T3 breast cancer conformed by biopsy, preoperative axillary ultrasound to confirm clinical node-negative status and indication for mastectomy with SLN procedure.
Intervention:
All included patients will receive standard of care implying 99mTc injection the day before surgery. Consequently, 5 mg (2 ml) ICG will be injected periareolar after administration of general anaesthesia and before incision. The lateral edge of the standard mastectomy incision will be used to explore the axilla for ICG fluorescent lymph nodes to avoid a separate axillary incision. Then the excised nodes are tested for 99mTc activity with the standard gamma detecting probe as control. Lastly, the axilla will be explored with the standard gamma-probe for residual lymph nodes, and by common sight and palpation as a control.
Outcomes:
Primary: to assess the detection rate of the ICG method to identify the SLN via a mastectomy incision.
Secondary:
- The detection rate of 99mTc
- The difference in detection rate between ICG and 99mTc
- The median number of SLN identified with ICG and the standard 99mTc
- Percentage of SLNs that is fluorescent, but not positive for 99mTc
- Percentage of SLNs that are not fluorescent but positive for 99mTc
- The difference in pathology of the SLN found by ICG and 99mTc, including the difference between micro- and macro metastases (Mic and Mac resp.) and isolated tumor cells (ITCs)
- Detection time for the use of ICG to detect the SLN, defined as time between skin incision and SLN resection in minutes
- Complications, including wound infection, bleeding and lymphedema, of the combination of the ICG method and the standard 99mTc method to identify the SLN in mastectomies
- The number of serious adverse events from the combination of ICG and 99mTc
Risks and burden:
Consenting patients will not need to do anything extra than the standard of care outside signing the informed consent. Administration of ICG will be done while under general anaesthesia, so patients will not experience extra discomfort, neither do they need extra site visits as the follow-up will be done during the standard follow-up appointment. ICG is safe to use: it is nonionizing and knows little to no complications and adverse events. Considering the cut-off of 2 additional nodes, the preferable topographic location of these nodes and the clinical experience with additional lymph node sampling, no increase in risk of surgical morbidity is expected. Patients might benefit from the intervention as ICG can increase the identification rate of the sentinel lymph node procedure and might even replace 99mTc for SLN mapping. Thus, both risks and burden are minimal.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive both indocyanine green (ICG) fluorescence imaging and standard 99mTc-nanocolloid sentinel lymph node mapping during the same surgical procedure. The procedure is primarily performed using ICG fluorescence imaging, with 99mTc serving as the control method to assess the diagnostic performance of ICG compared to 99mTc. Each patient serves as her own control in this within-subject comparison.
| Arm | Type | Receives |
|---|---|---|
| ICG-fluorescence imaging with 99mTc control for SLNB | Experimental | Other: Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsyThis experimental arm involves participants receiving indocyanine green (ICG) fluorescence imaging as the primary method for sentinel lymph node biopsy (SLNB), with 99mTc-nanocolloid serving as the within-patient control. Both methods are applied during the same surgical procedure. This design allows each participant to serve as their own control for comparing the diagnostic perfomance of both techniques directly in indentifying sentinel lymph nodes via mastectomy incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically node-negative, DCIS, invasive T1- T3 breast cancer confirmed by biopsy.
- Preoperative axillary ultrasound to confirm clinical node-negative status.
- Indication (or preference) for mastectomy and simultaneous SLN procedure.
- Written informed consent according to ICH/GCP and national regulations.
Key exclusion criteria (8 listed)
- Patients < 18 years old
- Breast conserving surgery
- Direct reconstruction (with autologous tissue or implant)
- Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc), intravenous contrast or iodine
- Other concurrent solid tumour
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 |
|---|---|---|
| Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsyICG-fluorescence is used as the primary tracer to identify SLNs during SLNB in breast cancer surgery. The standard 99mTc-nanocolloid method is used as a control to verify the sentinel lymph nodes identified by ICG. Surgeons are blinded to preoperative lymphoscintigraphy results. After general anesthesia, 5 mg (2 mL of 2.5 mg/mL solutio) of ICG is injected sub-/intracutaneous periareolarly. ICG-fluorescence is detected using near-infrared imaging. SLNB via mastectomy incision is performed. The most fluorescent lymph node is excised first, followed by (maximal 2) additional fluorescent nodes. The excised nodes are tested for 99mTc-activity using a gamma probe. The axilla is then checked with the gamma probe and and palpation for any remaining nodes, which are excised if their radiation count exceeds 10% of the hottest node. All excised lymph nodes are sent for pathological examination to determine the presence of cancer cells. After surgery, the lymphoscintigraphy results are announced. | Other | ICG-fluorescence imaging with 99mTc control for SLNB |
Primary outcome
Identification rate of sentinel lymph nodes using indocyanine green fluorescence
Time frame: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
The identification rate is defined as the proportion of participants in whom at least one sentinel lymph node (SLN) is successfully identified using indocyanine green (ICG) fluorescence imaging via the mastectomy incision during surgery.
10 secondary outcomes
Identification rate of sentinel lymph nodes using 99mTc
Time frame: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Difference in sentinel lymph node detection rate between ICG and 99mTc
Time frame: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Number of sentinel lymph nodes identified per participant by ICG and 99mTc
Time frame: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Proportion of participants with fluorescent sentinel lymph nodes among those identified by 99mTc
Time frame: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Fluorescent sentinel lymph nodes not positive for 99mTc
Time frame: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Sentinel lymph nodes positive for 99mTc but not fluorescent
Time frame: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)
Pathological status of sentinel lymph nodes identified by ICG and 99mTc
Time frame: From surgical resection of sentinel lymph nodes until completion of histopathological assessment, assessed within approximately 3 weeks after surgery
Detection time for sentinel lymph node identification using ICG
Time frame: During the surgical procedure (from skin incision to sentinel lymph node resection)
Procedure-related complications associated with ICG and 99mTc
Time frame: From surgery up to 2 months postoperatively
Serious adverse events related to ICG and 99mTc
Time frame: From surgery up to 2 months 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 23 Jan 2026.
- Individual participant dataSharing planned: Undecided. At present, there is no final decision regarding sharing of individual participant data (IPD). Data sharing will depend on ethical approval, participant consent, and compliance with applicable privacy regulations. If IPD sharing is pursued, only de-identified datasets relevant to the research question will be made available upon reasonable request to qualified researchers, under a data use agreement ensuring confidentiality and scientific integrity
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy in people with Breast Cancer and Sentinel Lymph Node Biopsy (SLNB), run by Isabelle Henskens at 2 sites in Netherlands.
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 4 inclusion and 8 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 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 Isabelle Henskens, MD (+31883202902, i.henskens@antoniusziekenhuis.nl), 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 nodes using indocyanine green fluorescence (time frame: During the surgical procedure (from skin incision to completion of sentinel lymph node resection)). 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 23 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.