Breast CancerFLUORESNCT05588414
Performance Assessment of the Fluorescence Technique Alone in the Search for the Sentinel Node in Breast Surgery
A study testing Standardization of the sentinel node detection procedure in people with Breast Cancer, run by Centre Hospitalier Annecy Genevois at 5 sites in France.
Trial summary
Cohort, interventional, multicenter, non-randomized study to compare the performance of the ICG fluorescence technique (ICG) alone to the combined ICG + isotopic technique in the detection of sentinel node. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standardization of the sentinel node detection procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 5 sitesFrance
- Study dates
- 5 Dec 2022to 27 Jun 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years of age on the day of inclusion,
- Presenting with breast cancer,
- Fulfilling the Sentinel Node search criteria of:
- Patient with carcinoma in situ with high risk of microinvasion:
- nodular presentation, high grade with necrosis,
- suspicion of microinvasion at biopsy,
Show all 14Show fewer
- radiological size of more than 40 mm,
- need for mastectomy or extensive resection requiring a complex oncoplasty surgery (no size criteria, at the surgeon's discretion)
- Patient with T1-T2 invasive carcinoma AND no lymph node involvement according to Tumor-Node-Metastasis (TNM) classification (N0) on clinical and imaging (negative axillary echo or negative lymph node biopsy):
- unifocal or bifocal proximal tumor
- < 5 cm (clinical), palpable or non-palpable (subcentimetric allowed)
- in case of neoadjuvant chemotherapy: before or after if N0 and negative axillary echo or negative biopsy
- Benefiting from a French social security system
- Having been informed of the study and having freely given their informed consent to participate in the study.
Who cannot join
- Pregnant or breastfeeding patient
- Patient not eligible for the sentinel node procedure (contraindication to surgery, N+ and/or M+ clinical or radiological, T3 and more, history of homolateral breast cancer surgery)
- Patient under guardianship or curators
- Patient under court protection
- Patient who does not understand French
- Patient already included in the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Hospitalier Annecy Genevois
Annecy, 74370
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, 38043
Hôpital Privé Drôme Ardèche
Guilherand-Granges, 07500
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, 69004
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Performance Assessment of the Fluorescence Technique Alone in the Search for the Sentinel Node in Breast Surgery, Compared to the Use of the Combined Fluorescence and Isotopic Method
Cohort, interventional, multicenter, non-randomized study to compare the performance of the ICG fluorescence technique (ICG) alone to the combined ICG + isotopic technique in the detection of sentinel node.
Comparison of the performances of two techniques used in current practice, without modification of the patients' care plan. Indeed, all patients receive both techniques, but the protocol allows to standardize the collection of the performances of each of the two techniques in order to compare them.
- Conditions
- Breast Cancer
- Being tested
- Standardization of the sentinel node detection procedure
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardization of the sentinel node detection procedureProcedure or surgery
All patients included in the study underwent the same pre- and intra-operative procedure, consisting of a double systematic sentinel node detection, using sequential ICG and isotopic technique. The patient is his own control for the analysis of the performance of the ICG technique alone compared to the combined ICG and isotopic technique.
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine Green fluorescence method as first step | Other | Systematic double identification of the sentinel lymph node, by sequential use of ICG fluorescence technique as first step followed by isotopic technique. Receives: Procedure: Standardization of the sentinel node detection procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method
The main objective is to evaluate the diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method alone as a sentinel node marker in non-metastatic breast cancer, compared to the method coupling technetium-99m isotopic research (TC) to fluorescence (Gold Standard in the study centers).
The suspicious node bundles, which will have been removed after identification by 1) ICG alone, 2) TC alone or 3) manually, can be classified in a contingency table, according to the first method (the sequence) with which they are detected.
The Sensitivity / Specificity pair will then be used to :
- Estimate the area under the curve (AUC) of the ICG method alone, and its 95% confidence interval.
- Estimate the positive and negative predictive values of ICG alone, using the prevalence of metastatic lesions.
Measured: At time of surgery
Secondary outcomes (5)
Frequency and factors associated with the occurrence of false negatives (FN) related to the use of ICG alone (fluorescence tracking failure alone)
The number and percentage of lymph node packages detected only by isotopic method. Analysis of the factors (patient characteristics such as total mastectomy vs. partial mastectomy, obesity, tumor location in the mammary gland) associated with the occurrence of these false negatives, using a multivariate logistic regression model.
Measured: At time of surgery
Frequency of detection on table by multispectral camera, of ganglions first detected only by isotopic method.
Number and percentage of ganglion bundles detected only by isotopic method, among which we will finally find a marking with the multispectral camera.
Measured: At time of surgery
Causes of premature use of the isotope method (moving to the second stage of tracking) before the first stage of tracking (ICG method) has been completed.
Frequencies of pre-identified causes of premature isotopic use during the first stage of the axillary procedure. The pre-identified causes are the follows:
- Poor skin visualization
- Operative difficulty with persistence of a fluorescent signal
- Loss of fluorescent signal
- Loss of surgeon patience
- Other.
Measured: At time of surgery
Surgeon's perception of the usefulness and self-perceived satisfaction of ICG method alone, compared with the combined technique (ICG+TC).
Description of the surgeon's self-perceived satisfaction with the use of the ICG alone, using individualized 10-point Likert scales (0 = not at all useful/satisfied; 10 = quite useful/satisfied).
Measured: At time of surgery
Interest of the ICG technique alone compared to the combined technique for the detection of metastases.
Diagnostic performance of ICG method to identify sentinel node will be associated with the frequency of detection of metastases (weighted by the number of nodes present in the lymph node packages sent to pathology) in order to evaluate the diagnostic performance of this method as sentinel metastatic node marker.
Measured: Upon receipt of the anatomopathology results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start5 Dec 2022
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier TARDIF, Doctor, Principal investigator, Centre Hospitalier Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588414
- Sponsor's protocol ID
- 21-04
- Acronym
- FLUORES
- Status last verified
- Feb 2025
- First submitted
- 14 Oct 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment of the Fluorescence Technique Alone in the Search for the Sentinel Node in Breast Surgery, Compared to the Use of the Combined Fluorescence and Isotopic Method
- ClinicalTrials.gov ID
- NCT05588414
- Acronym / sponsor ID
- FLUORES / 21-04
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 20 Oct 2022 (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.
Cohort, interventional, multicenter, non-randomized study to compare the performance of the ICG fluorescence technique (ICG) alone to the combined ICG + isotopic technique in the detection of sentinel node.
Comparison of the performances of two techniques used in current practice, without modification of the patients' care plan. Indeed, all patients receive both techniques, but the protocol allows to standardize the collection of the performances of each of the two techniques in order to compare them.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indocyanine Green fluorescence method as first step | Other | Procedure: Standardization of the sentinel node detection procedureSystematic double identification of the sentinel lymph node, by sequential use of ICG fluorescence technique as first step followed by isotopic technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient over 18 years of age on the day of inclusion,
- Presenting with breast cancer,
- Fulfilling the Sentinel Node search criteria of:
- nodular presentation, high grade with necrosis,
- suspicion of microinvasion at biopsy,
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding patient
- Patient not eligible for the sentinel node procedure (contraindication to surgery, N+ and/or M+ clinical or radiological, T3 and more, history of homolateral breast cancer surgery)
- Patient under guardianship or curators
- Patient under court protection
- Patient who does not understand French
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 |
|---|---|---|
| Standardization of the sentinel node detection procedureAll patients included in the study underwent the same pre- and intra-operative procedure, consisting of a double systematic sentinel node detection, using sequential ICG and isotopic technique. The patient is his own control for the analysis of the performance of the ICG technique alone compared to the combined ICG and isotopic technique. | Procedure or surgery | Indocyanine Green fluorescence method as first step |
Primary outcome
Diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method
Time frame: At time of surgery
The main objective is to evaluate the diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method alone as a sentinel node marker in non-metastatic breast cancer, compared to the method coupling technetium-99m isotopic research (TC) to fluorescence (Gold Standard in the study centers). The suspicious node bundles, which will have been removed after identification by 1) ICG alone, 2) TC alone or 3) manually, can be classified in a contingency table, according to the first method (the sequence) with which they are detected. The Sensitivity / Specificity pair will then be used to : 1. Estimate the area under the curve (AUC) of the ICG method alone, and its 95% confidence interval. 2. Estimate the positive and negative predictive values of ICG alone, using the prevalence of metastatic lesions.
5 secondary outcomes
Frequency and factors associated with the occurrence of false negatives (FN) related to the use of ICG alone (fluorescence tracking failure alone)
Time frame: At time of surgery
Frequency of detection on table by multispectral camera, of ganglions first detected only by isotopic method.
Time frame: At time of surgery
Causes of premature use of the isotope method (moving to the second stage of tracking) before the first stage of tracking (ICG method) has been completed.
Time frame: At time of surgery
Surgeon's perception of the usefulness and self-perceived satisfaction of ICG method alone, compared with the combined technique (ICG+TC).
Time frame: At time of surgery
Interest of the ICG technique alone compared to the combined technique for the detection of metastases.
Time frame: Upon receipt of the anatomopathology results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Didier TARDIF, Doctor principal investigator
Centre Hospitalier Annecy Genevois
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardization of the sentinel node detection procedure in people with Breast Cancer, run by Centre Hospitalier Annecy Genevois at 5 sites in France.
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 14 inclusion and 6 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: finished, as of the sponsor's last update on 13 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 5 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (Sensitivity and Specificity) of the indocyanine green fluorescence (ICG) method (time frame: At time 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 13 Feb 2025.