Breast CancerSHINENCT06085274
Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)
A study testing ICG guided sentinel lymph node biopsy in people with Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a prospective, open-label, within-patient clinical trial to determine the accuracy of Indocyanine green (ICG) guided sentinel lymph node biopsy (SLNB) compared to the standard dual-tracer SLNB in breast cancer patients who have had chemotherapy as a first treatment using a non-inferiority design. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ICG guided sentinel lymph node biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 3 Sep 2025to Jul 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 and ≤ 80
- Stage I-III core biopsy confirmed invasive breast cancer, who have undergone neoadjuvant chemotherapy and are planned to undergo SLNB with dual tracer (blue dye+Tc-99m)
- Eastern Cooperative Oncology Group (ECOG) < 2
- No ICG/iodine allergy
- Capable of providing informed consent
- English literacy
Who cannot join
- Significant medical comorbidities (ASA 4)
- Breast cancer stage T4/inflammatory or N2 disease at presentation (SLNB is contra-indicated in this setting)
- Clinical node positive after neoadjuvant therapy (SLNB is contra-indicated in this setting)
- Previous axillary surgery or breast/axillary radiotherapy to ipsilateral breast
- Active pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G2M9
Tulin Cil, MD, MEd, 4169464507, tulin.cil@uhn.ca
Emma Reel, MSW, 6472021028, emma.reel@uhn.ca
About this study
Official title: Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE): A Prospective Clinical Trial
This is a prospective, open-label, within-patient clinical trial to determine the accuracy of Indocyanine green (ICG) guided sentinel lymph node biopsy (SLNB) compared to the standard dual-tracer SLNB in breast cancer patients who have had chemotherapy as a first treatment using a non-inferiority design.
Patients with operable breast cancer treated with chemotherapy and eligible for SLNB will be included in the study. During surgery, ICG will be injected and used to identify fluorescent sentinel nodes using a hand-held imaging camera; radiotracer and blue dye will also be used as per standard protocols. Intraoperative and clinicopathologic outcomes such as complications, characteristics of nodes, false negative rates and feasibility will be assessed. Patients will be asked to complete standardized patient reported outcome questionnaires (Breast-Q, FACT-B+4, VAS) to define the patient experience with this novel technique.
- Conditions
- Breast Cancer
- Being tested
- ICG guided sentinel lymph node biopsy
- Keywords
- Invasive breast cancer, Indocyanine green, Sentinel lymph node biopsy, Neoadjuvant 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.
ICG guided sentinel lymph node biopsyProcedure or surgery
During sentinel lymph node biopsy the surgeon will inject a volume of 0.1ml divided into 2 doses (0.05ml each) of 2.5mg/mL ICG into the periareolar dermis of the involved breast. Technetium and blue dye will also be administered as per standard of care. The surgeon will assess the axilla with the the SPY-PHI near infrared imaging system to identify and remove ICG-fluorescent nodes; Any other sentinel lymph nodes identified will also be removed as per standard of care. If there is no progression of ICG towards the axilla, or if no ICG sentinel lymph node can be identified, an alternate injection technique involving peritumoural injection at 2-3 locations near the cancer site in the subcutaneous or dermal space of 0.05ml will be utilized.
| Study group | Role | What they receive |
|---|---|---|
| ICG-SLNB | Experimental | This is a prospective within-patient clinical study to assess the accuracy of ICG SLNB compared to standard dual-tracer SLNB in breast cancer patients treated with neoadjuvant chemotherapy. For SLNB, triple localization of the sentinel lymph nodes using blue dye, Tc-99m and ICG will be utilized in each patient. Receives: Procedure: ICG guided sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of ICG SLNB compared to dual-tracer SLNB in post-neoadjuvant chemotherapy treated breast cancer patients.
Proportion of lymph nodes identified with ICG compared to the proportion of lymph nodes identified with dual tracer (blue dye/Tc-99m gamma probe)
Measured: From Technetium-99 (Tc-99m) injection to the completion of surgery
Secondary outcomes (4)
Complications/safety
Surgical intra-operative and post-operative complications will be collected to determine safety outcomes. All intra-operative complications will be graded using the ClassIntra classification. All post-operative complications (up to 30 days post-surgical treatment) will be graded using the Clavien-Dindo classification. Treatment-related adverse events will be assessed by CTCAE v5.0.
Measured: From time of Technetium-99 (Tc-99m) injection to 30 days after surgery
Patient reported outcome measures - Visual Analog Scale
Patients' self-report the intensity of their pain. Scale 0-10, where 10 indicated worst pain possible.
Measured: From baseline/enrolment to 12 months from surgery
Patient reported outcome measures - FACT-B+4
Breast cancer patients' self-report on various dimensions of their Quality of Life: Measures physical well-being (score range 0-28; higher score = worse outcome), social/family well-being (score range 0-28; higher score = better outcome), emotional well-being (score range 0-24; higher score = worse outcome), functional well-being (score range 0-28; higher score = better outcome), breast cancer subscale (score range 0-28; higher score = worse outcome), lymphedema subscale (score range 0-20; higher score = worse outcome).
Measured: From baseline/enrolment to 12 months from surgery
Patient reported outcome measures - Breast-Q
Breast cancer patients' self-report their perceptions of domains of Quality of Life. Scale 0-100; 100 indicates better satisfaction.
Measured: From baseline/enrolment to 12 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start3 Sep 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (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.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085274
- Sponsor's protocol ID
- 20-6215.0
- Acronym
- SHINE
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE): A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06085274
- Acronym / sponsor ID
- SHINE / 20-6215.0
- Conditions
- Breast Cancer
- Keywords
- Invasive breast cancer, Indocyanine green, Sentinel lymph node biopsy, Neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 16 Oct 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.
This is a prospective, open-label, within-patient clinical trial to determine the accuracy of Indocyanine green (ICG) guided sentinel lymph node biopsy (SLNB) compared to the standard dual-tracer SLNB in breast cancer patients who have had chemotherapy as a first treatment using a non-inferiority design.
Patients with operable breast cancer treated with chemotherapy and eligible for SLNB will be included in the study. During surgery, ICG will be injected and used to identify fluorescent sentinel nodes using a hand-held imaging camera; radiotracer and blue dye will also be used as per standard protocols. Intraoperative and clinicopathologic outcomes such as complications, characteristics of nodes, false negative rates and feasibility will be assessed. Patients will be asked to complete standardized patient reported outcome questionnaires (Breast-Q, FACT-B+4, VAS) to define the patient experience with this novel technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG-SLNB | Experimental | Procedure: ICG guided sentinel lymph node biopsyThis is a prospective within-patient clinical study to assess the accuracy of ICG SLNB compared to standard dual-tracer SLNB in breast cancer patients treated with neoadjuvant chemotherapy. For SLNB, triple localization of the sentinel lymph nodes using blue dye, Tc-99m and ICG will be utilized in each patient. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥ 18 and ≤ 80
- Stage I-III core biopsy confirmed invasive breast cancer, who have undergone neoadjuvant chemotherapy and are planned to undergo SLNB with dual tracer (blue dye+Tc-99m)
- Eastern Cooperative Oncology Group (ECOG) < 2
- No ICG/iodine allergy
- Capable of providing informed consent
Key exclusion criteria (5 listed)
- Significant medical comorbidities (ASA 4)
- Breast cancer stage T4/inflammatory or N2 disease at presentation (SLNB is contra-indicated in this setting)
- Clinical node positive after neoadjuvant therapy (SLNB is contra-indicated in this setting)
- Previous axillary surgery or breast/axillary radiotherapy to ipsilateral breast
- Active pregnancy or breastfeeding
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 |
|---|---|---|
| ICG guided sentinel lymph node biopsyDuring sentinel lymph node biopsy the surgeon will inject a volume of 0.1ml divided into 2 doses (0.05ml each) of 2.5mg/mL ICG into the periareolar dermis of the involved breast. Technetium and blue dye will also be administered as per standard of care. The surgeon will assess the axilla with the the SPY-PHI near infrared imaging system to identify and remove ICG-fluorescent nodes; Any other sentinel lymph nodes identified will also be removed as per standard of care. If there is no progression of ICG towards the axilla, or if no ICG sentinel lymph node can be identified, an alternate injection technique involving peritumoural injection at 2-3 locations near the cancer site in the subcutaneous or dermal space of 0.05ml will be utilized. | Procedure or surgery | ICG-SLNB |
Primary outcome
Non-inferiority of ICG SLNB compared to dual-tracer SLNB in post-neoadjuvant chemotherapy treated breast cancer patients.
Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery
Proportion of lymph nodes identified with ICG compared to the proportion of lymph nodes identified with dual tracer (blue dye/Tc-99m gamma probe)
4 secondary outcomes
Complications/safety
Time frame: From time of Technetium-99 (Tc-99m) injection to 30 days after surgery
Patient reported outcome measures - Visual Analog Scale
Time frame: From baseline/enrolment to 12 months from surgery
Patient reported outcome measures - FACT-B+4
Time frame: From baseline/enrolment to 12 months from surgery
Patient reported outcome measures - Breast-Q
Time frame: From baseline/enrolment to 12 months from surgery
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 30 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG guided sentinel lymph node biopsy in people with Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 6 inclusion and 5 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 30 Oct 2026. 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 Canada. 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 Tulin Cil, MD MSc FRCSC (416-946-4501 ext. 3984, tulin.cil@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of ICG SLNB compared to dual-tracer SLNB in post-neoadjuvant chemotherapy treated breast cancer patients. (time frame: From Technetium-99 (Tc-99m) injection to the completion 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 30 Oct 2026.