Breast CancerBREASTIFLU-1NCT06227338
ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study
A study testing Indocyanine green in people with Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
Designed in five-arm, single-center, prospective randomized, observational- interventional, open-label study which will evaluate patients with histological proven early-stage BC that will undergo planned BCS for their local treatment. 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?
- Indocyanine green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Feb 2024to 1 Jan 2026
- 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
- female;
- age of ≥18 years;
- histological diagnosis of ductal invasive breast cancer;
- a primary early-stage invasive breast cancer (cT1 and/or cT2, assessed clinically and/or radiologically), without prior BC surgery of the actually affected breast;
- ECOG Performance Status (PS) 0 or 1;
- signed informed consent form (ICF) obtained prior to any study related procedure.
Who cannot join
- advanced invasive breast cancer (cT3 and/or cT4);
- in situ breast cancer disease;
- lobular invasive breast cancer (at histology);
- invasive breast cancer treated by neoadjuvant chemotherapy and/or endocrine therapy;
- prior history of invasive or breast cancer of the actually affected breast in the past;
- history of allergy or hypersensitivity to investigational product (active substance or ingredients);
Show all 14Show fewer
- history of allergy to iodine or to shellfish;
- have apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal, or disseminated autonomy of the thyroid gland;
- documented coronary disease
- advanced renal insufficiency (serum creatinine >1.5 mg/dL);
- chronic liver disease with the Child-Pugh class B or C ;
- concurrent medication which reduces or increases the elimination of indocyanine green dye (ie, anticonvulsants, haloperidol, and heparin) during the 2 weeks before the expected operation;
- pregnant or lactating women;
- inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Jules Bordet Institute
Brussels, 1070
Florin Pop, MD, +322541 ext. 3244, catalin.florin.pop@hubruxelles.be
Sophie Vankerckhove, +322541 ext. 7341, sophie.vankerckhove@hubruxelles.be
About this study
Designed in five-arm, single-center, prospective randomized, observational- interventional, open-label study which will evaluate patients with histological proven early-stage BC that will undergo planned BCS for their local treatment.
Two preoperatively times frames will be used for the administration of a total of 5 different indocyanine green (ICG) dose as a single dose-patient arm.
Read more
In the first time frame (intraoperative arms), the dose of, respectively 0.125 mg/kg and 0.25 mg/kg of ICG will be administered at induction anesthesia (at least 20 minutes before the BCS) in two subgroups.
In the second time frame, (preoperative arms), the dose of, respectively, 0.5 mg/kg, 1 mg/kg, and 2 mg/kg of ICG will be administered 24 h before surgery in 3 subgroups.
Read the detailed description
The majority of breast cancer (BC) patients are diagnosed with an early-stage disease and are good candidates for breast-conserving surgery (BCS). Achieving adequate margins of excision is the most important component of BCS. Currently intra-operative margin assessment (IOMA) techniques used for margins evaluation in BC, either histological or imagistic is not accurate enough to predict the margins status of breast resected tumours and to guide surgery.
Fluorescence imaging (FI) using indocyanine green (ICG), a non-specific fluorophore, has also been reported to be a new, promising, non-invasive and relatively low cost technology to improving the accuracy of tumor detection during surgery in different clinical cancers, such as those of the liver, colon, ovaries, head and neck, lungs and breast. Furthermore ICG-FI can provide a real-time guidance during surgery and could establish corrects margins resection by improving the visual delineation between normal and tumoral tissues.
Only two clinical experience of ICG-FI for evaluating surgical margins in BC was reported. The group of Keating reported the first one, in a pilot study of 12 patients, after ICG intravenous (IV) injection (5mg/kg) they found that there was residual fluorescence in the tumoral bed in 6 out of 12 patients, but none of these patients had positive margins at definitive pathology. Recently, the investigators have reported the utility of ICG-FI after intraoperative ICG IV injection of 0.25 mg/kg for intraoperative breast surgical margin assessment during BCS. In a study of 35 BC patients, the investigators observed that the sensitivity (Se), specificity (Sp), and negative predictive value (NPV), of ICG-FI to predict margin involvement on the breast operative specimens were 100%, 60% and 100% respectively. Several important technical points exist in the experimental and clinical use of ICG-FI. There is a great variability of the published data regarding the baseline characteristics of the ICG use, like dosage and timing of administration (perioperative vs delayed). Furthermore, the fluorescence imaging system is usually different.
In this study, the investigators would like to emphasize and to get more precision about the optimal ICG doses and timing, which could increase the diagnostic accuracy of intraoperative ICG-FI for resection margins assessment during BCS, after intravenously ICG administration.
- Conditions
- Breast Cancer
- Being tested
- Indocyanine green
- Keywords
- Breast cancer, Conservative surgery, 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.
Indocyanine greenDrug
Indocyanine green dye (Diagnostic Green) will be diluted with sterile water and a specific dose-arm (0.125 mg/kg, 0.25 mg/kg, 05 mg/kg, 1 mg/kg, and 2 mg/kg) will be administrated by slow intravenous injection by peripheral venous catheter:
- at induction anaesthesia of the surgical procedure (0.125 mg/kg or 0.25mg/kg), or
- in the hospital room 24 hours before the breast surgery (05 mg/kg, or 1 mg/kg, or 2 mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| 0.125 mg/kg | Experimental | Patients who will be injected with 0.125 mg/kg Indocyanine green before their tumorectomy Receives: Drug: Indocyanine green |
| 0.25 mg/kg | Experimental | Patients who will be injected with 0.25 mg/kg Indocyanine green before their tumorectomy Receives: Drug: Indocyanine green |
| 0.5 mg/kg | Experimental | Patients who will be injected with 0.5 mg/kg Indocyanine green before their tumorectomy Receives: Drug: Indocyanine green |
| 1 mg/kg | Experimental | Patients who will be injected with 1 mg/kg Indocyanine green before their tumorectomy Receives: Drug: Indocyanine green |
| 2 mg/kg | Experimental | Patients who will be injected with 2 mg/kg Indocyanine green before their tumorectomy Receives: Drug: Indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of ICG-FI technique for the detection of positive (involved) surgical margins at the patient level
The sensitivity (Se), specificity (Sp), negative predictive value (NPV), false negative rate (FNR), FPR of the ICG-FI technique will be computed at the patient level
Measured: 2 years
Secondary outcomes (3)
Comparison of ICG-FI technique accuracy at different doses and timing
The sensitivity (Se), specificity (Sp), negative predictive value (NPV), false negative rate (FNR), FPR of the ICG-FI technique will be computed
Measured: 2 years
Characterization of the breast tumor fluorescence (tumor-to- background fluorescence ratio)
Characterization of the appearance and intensity of fluorescence at the level of tumor cells
Measured: 2 years
Evaluation of fluorescence intensity of axillary lymph nodes
The distribution of fluorescence intensity will be calculated depending on the type of axillary lymph node (LN) : sentinel vs other and respectively metastatic LN vs healthy LN)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start12 Feb 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Indocyanine green dye (Diagnostic Green) will be diluted with sterile water and a specific dose-arm (0.125 mg/kg, 0.25 mg/kg, 05 mg/kg, 1 mg/kg, and 2 mg/kg) will be administrated by slow intravenous injection by peripheral venous catheter: * at induction anaesthesia of the surgical procedure (0.125 mg/kg or 0.25mg/kg), or * in the hospital room 24 hours before the breast surgery (05 mg/kg, or 1 mg/kg, or 2 mg/kg).
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florin Pop, MD, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227338
- Sponsor's protocol ID
- IJB-S2022-IFIBC01
- Acronym
- BREASTIFLU-1
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2023
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pop CF, Veys I, Moreau M, Paesmans M, De Azambuja E, Larsimont D, Liberale G. Intraoperative breast cancer margin evaluation using fluorescence imaging with intravenous injection of indocyanine green (BREASTIFLU-1): study protocol for a randomized diagnostic accuracy trial of quantitative dose-timing assessment. Trials. 2026 Mar 3;27(1):288. doi: 10.1186/s13063-026-09577-8.
PubMed 41772708
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study
- ClinicalTrials.gov ID
- NCT06227338
- Acronym / sponsor ID
- BREASTIFLU-1 / IJB-S2022-IFIBC01
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Conservative surgery, Indocyanine Green
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 26 Jan 2024 (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.
Designed in five-arm, single-center, prospective randomized, observational- interventional, open-label study which will evaluate patients with histological proven early-stage BC that will undergo planned BCS for their local treatment.
Two preoperatively times frames will be used for the administration of a total of 5 different indocyanine green (ICG) dose as a single dose-patient arm.
In the first time frame (intraoperative arms), the dose of, respectively 0.125 mg/kg and 0.25 mg/kg of ICG will be administered at induction anesthesia (at least 20 minutes before the BCS) in two subgroups.
In the second time frame, (preoperative arms), the dose of, respectively, 0.5 mg/kg, 1 mg/kg, and 2 mg/kg of ICG will be administered 24 h before surgery in 3 subgroups.
Detailed description
The majority of breast cancer (BC) patients are diagnosed with an early-stage disease and are good candidates for breast-conserving surgery (BCS). Achieving adequate margins of excision is the most important component of BCS. Currently intra-operative margin assessment (IOMA) techniques used for margins evaluation in BC, either histological or imagistic is not accurate enough to predict the margins status of breast resected tumours and to guide surgery.
Fluorescence imaging (FI) using indocyanine green (ICG), a non-specific fluorophore, has also been reported to be a new, promising, non-invasive and relatively low cost technology to improving the accuracy of tumor detection during surgery in different clinical cancers, such as those of the liver, colon, ovaries, head and neck, lungs and breast. Furthermore ICG-FI can provide a real-time guidance during surgery and could establish corrects margins resection by improving the visual delineation between normal and tumoral tissues.
Only two clinical experience of ICG-FI for evaluating surgical margins in BC was reported. The group of Keating reported the first one, in a pilot study of 12 patients, after ICG intravenous (IV) injection (5mg/kg) they found that there was residual fluorescence in the tumoral bed in 6 out of 12 patients, but none of these patients had positive margins at definitive pathology. Recently, the investigators have reported the utility of ICG-FI after intraoperative ICG IV injection of 0.25 mg/kg for intraoperative breast surgical margin assessment during BCS. In a study of 35 BC patients, the investigators observed that the sensitivity (Se), specificity (Sp), and negative predictive value (NPV), of ICG-FI to predict margin involvement on the breast operative specimens were 100%, 60% and 100% respectively. Several important technical points exist in the experimental and clinical use of ICG-FI. There is a great variability of the published data regarding the baseline characteristics of the ICG use, like dosage and timing of administration (perioperative vs delayed). Furthermore, the fluorescence imaging system is usually different.
In this study, the investigators would like to emphasize and to get more precision about the optimal ICG doses and timing, which could increase the diagnostic accuracy of intraoperative ICG-FI for resection margins assessment during BCS, after intravenously ICG administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Indocyanine green dye (Diagnostic Green) will be diluted with sterile water and a specific dose-arm (0.125 mg/kg, 0.25 mg/kg, 05 mg/kg, 1 mg/kg, and 2 mg/kg) will be administrated by slow intravenous injection by peripheral venous catheter: * at induction anaesthesia of the surgical procedure (0.125 mg/kg or 0.25mg/kg), or * in the hospital room 24 hours before the breast surgery (05 mg/kg, or 1 mg/kg, or 2 mg/kg).
| Arm | Type | Receives |
|---|---|---|
| 0.125 mg/kg | Experimental | Drug: Indocyanine greenPatients who will be injected with 0.125 mg/kg Indocyanine green before their tumorectomy |
| 0.25 mg/kg | Experimental | Drug: Indocyanine greenPatients who will be injected with 0.25 mg/kg Indocyanine green before their tumorectomy |
| 0.5 mg/kg | Experimental | Drug: Indocyanine greenPatients who will be injected with 0.5 mg/kg Indocyanine green before their tumorectomy |
| 1 mg/kg | Experimental | Drug: Indocyanine greenPatients who will be injected with 1 mg/kg Indocyanine green before their tumorectomy |
| 2 mg/kg | Experimental | Drug: Indocyanine greenPatients who will be injected with 2 mg/kg Indocyanine green before their tumorectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- female;
- age of ≥18 years;
- histological diagnosis of ductal invasive breast cancer;
- a primary early-stage invasive breast cancer (cT1 and/or cT2, assessed clinically and/or radiologically), without prior BC surgery of the actually affected breast;
- ECOG Performance Status (PS) 0 or 1;
Key exclusion criteria (14 listed)
- advanced invasive breast cancer (cT3 and/or cT4);
- in situ breast cancer disease;
- lobular invasive breast cancer (at histology);
- invasive breast cancer treated by neoadjuvant chemotherapy and/or endocrine therapy;
- prior history of invasive or breast cancer of the actually affected breast in the past;
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 greenIndocyanine green dye (Diagnostic Green) will be diluted with sterile water and a specific dose-arm (0.125 mg/kg, 0.25 mg/kg, 05 mg/kg, 1 mg/kg, and 2 mg/kg) will be administrated by slow intravenous injection by peripheral venous catheter: * at induction anaesthesia of the surgical procedure (0.125 mg/kg or 0.25mg/kg), or * in the hospital room 24 hours before the breast surgery (05 mg/kg, or 1 mg/kg, or 2 mg/kg). | Drug | 0.125 mg/kg, 0.25 mg/kg, 0.5 mg/kg, 1 mg/kg, 2 mg/kg |
Primary outcome
Accuracy of ICG-FI technique for the detection of positive (involved) surgical margins at the patient level
Time frame: 2 years
The sensitivity (Se), specificity (Sp), negative predictive value (NPV), false negative rate (FNR), FPR of the ICG-FI technique will be computed at the patient level
3 secondary outcomes
Comparison of ICG-FI technique accuracy at different doses and timing
Time frame: 2 years
Characterization of the breast tumor fluorescence (tumor-to- background fluorescence ratio)
Time frame: 2 years
Evaluation of fluorescence intensity of axillary lymph nodes
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Derived from this study: PubMed 41772708Pop CF, Veys I, Moreau M, Paesmans M, De Azambuja E, Larsimont D, Liberale G. Intraoperative breast cancer margin evaluation using fluorescence imaging with intravenous injection of indocyanine green (BREASTIFLU-1): study protocol for a randomized diagnostic accuracy trial of quantitative dose-timing assessment. Trials. 2026 Mar 3;27(1):288. doi: 10.1186/s13063-026-09577-8.
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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.
Florin Pop, MD principal investigator
Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green in people with Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.
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 14 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 26 Feb 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 Belgium. 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 Florin Pop, MD (+322541 ext. 3244, catalin.florin.pop@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of ICG-FI technique for the detection of positive (involved) surgical margins at the patient level (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06227338, which also lists 1 linked publication.
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 26 Feb 2025.