Breast CancerNCT02875626
Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer
A study testing Infracyanine in people with Breast Cancer, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 1 site in France.
Trial summary
This is a single-center prospective study evaluating the diagnostic performance and safety of Infracyanine in women with early breast cancer whose the research of sentinel node(s) combines isotopes and Infracyanine. 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?
- Infracyanine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Mar 2019
- 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 > 18 years
- Invasive breast cancer ≤ 5 cm, unifocal bifocal or multifocal
- Diagnosis confirmed by biopsy
- Breast cancer extended in situ
- First surgical treatment
Who cannot join
- Neoadjuvant chemotherapy or hormone therapy.
- Multicentric tumor
- Pregnant patient
- Ongoing participation in another clinical trial with an investigational drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer (FLUO-BREAST)
This is a single-center prospective study evaluating the diagnostic performance and safety of Infracyanine in women with early breast cancer whose the research of sentinel node(s) combines isotopes and Infracyanine.
Read the detailed description
Visits:
Screening:
Complete physical and gynecological examination by surgical oncologist Informed and signed consent form. The intervention will be planned within one month.
Intervention:
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
The search or sentinel node will be made using a infrared camera for transcutaneous visualization Secondly, data lymphoscintigraphy may be communicated to the surgeon. The nodes are identified as SN fluorescent nodes and / or radioactive nodes.
- All radioactive nodes and / or fluorescent will be deleted
- Reports of anatomy fluorescent SN and / or hot
Next visit:
The patient will be reviewed in consultation in the months following the itervention for a clinical examination, the collection of adverse events.
- Conditions
- Breast Cancer
- Being tested
- Infracyanine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfracyanineDrug
Also called indocyanin green
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
| Study group | Role | What they receive |
|---|---|---|
| Infracyanine | Experimental | In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM). Receives: Drug: Infracyanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the SN detection rate during surgery by fluorescence, by isotopes, by combining the two. The detection rate is defined by the number of patient
The detection rate is defined by the number of patient who at least one axillary sentinel node detected by fluorescence and / or isotope intraoperatively / number of female patients injected.
Measured: During surgery
Secondary outcomes (6)
The time between the incision and removal of the first sentinel node identified
Measured: During surgery
The sensitivity of indocyanine green compared to the technical reference ( percentage of nodes detected by the isotope and which are also detected by the indocyanine green )
Measured: During surgery
The wrong negative rate (number of female patients in whom at least one metastatic sentinel node has been detected by isotope and not by ICG)
Measured: During surgery
Technical direct cost
Measured: during the study
Incidence rates of allergic reactions
Measured: From screening till 1 month after the surgery
Severity of allergic reactions (grade 1 to 5 according to Ring and al 38 )
Measured: From screening till 1 month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2019
- Study completionMar 2019
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte NGO, MD, Principal investigator, Hôpital Européen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875626
- Sponsor's protocol ID
- FLUOBREAST
- Status last verified
- May 2019
- First submitted
- 18 Aug 2016
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ngo C, Sharifzadehgan S, Lecurieux-Lafayette C, Belhouari H, Rousseau D, Bonsang-Kitzis H, Crouillebois L, Balaya V, Oudard S, Lecuru F, Elaidi RT. Indocyanine green for sentinel lymph node detection in early breast cancer: Prospective evaluation of detection rate and toxicity-The FLUOBREAST trial. Breast J. 2020 Dec;26(12):2357-2363. doi: 10.1111/tbj.14100. Epub 2020 Oct 22.
PubMed 33094498
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer (FLUO-BREAST)
- ClinicalTrials.gov ID
- NCT02875626
- Acronym / sponsor ID
- FLUOBREAST
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Association Pour La Recherche des Thérapeutiques Innovantes en CancérologieUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Feb 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 23 Aug 2016 (estimated)
- 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 single-center prospective study evaluating the diagnostic performance and safety of Infracyanine in women with early breast cancer whose the research of sentinel node(s) combines isotopes and Infracyanine.
Detailed description
Visits:
Screening:
Complete physical and gynecological examination by surgical oncologist Informed and signed consent form. The intervention will be planned within one month.
Intervention:
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
The search or sentinel node will be made using a infrared camera for transcutaneous visualization Secondly, data lymphoscintigraphy may be communicated to the surgeon. The nodes are identified as SN fluorescent nodes and / or radioactive nodes.
- All radioactive nodes and / or fluorescent will be deleted
- Reports of anatomy fluorescent SN and / or hot
Next visit:
The patient will be reviewed in consultation in the months following the itervention for a clinical examination, the collection of adverse events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infracyanine | Experimental | Drug: InfracyanineIn the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female age > 18 years
- Invasive breast cancer ≤ 5 cm, unifocal bifocal or multifocal
- Diagnosis confirmed by biopsy
- Breast cancer extended in situ
- First surgical treatment
Key exclusion criteria (4 listed)
- Neoadjuvant chemotherapy or hormone therapy.
- Multicentric tumor
- Pregnant patient
- Ongoing participation in another clinical trial with an investigational drug
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 |
|---|---|---|
| InfracyanineAlso: indocyanin greenIn the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM). | Drug | Infracyanine |
Primary outcome
The primary endpoint is the SN detection rate during surgery by fluorescence, by isotopes, by combining the two. The detection rate is defined by the number of patient
Time frame: During surgery
The detection rate is defined by the number of patient who at least one axillary sentinel node detected by fluorescence and / or isotope intraoperatively / number of female patients injected.
6 secondary outcomes
The time between the incision and removal of the first sentinel node identified
Time frame: During surgery
The sensitivity of indocyanine green compared to the technical reference ( percentage of nodes detected by the isotope and which are also detected by the indocyanine green )
Time frame: During surgery
The wrong negative rate (number of female patients in whom at least one metastatic sentinel node has been detected by isotope and not by ICG)
Time frame: During surgery
Technical direct cost
Time frame: during the study
Incidence rates of allergic reactions
Time frame: From screening till 1 month after the surgery
Severity of allergic reactions (grade 1 to 5 according to Ring and al 38 )
Time frame: From screening till 1 month after the surgery
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 5 Jul 2019.
- Derived from this study: PubMed 33094498Ngo C, Sharifzadehgan S, Lecurieux-Lafayette C, Belhouari H, Rousseau D, Bonsang-Kitzis H, Crouillebois L, Balaya V, Oudard S, Lecuru F, Elaidi RT. Indocyanine green for sentinel lymph node detection in early breast cancer: Prospective evaluation of detection rate and toxicity-The FLUOBREAST trial. Breast J. 2020 Dec;26(12):2357-2363. doi: 10.1111/tbj.14100. Epub 2020 Oct 22.
- 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.
Charlotte NGO, MD principal investigator
Hôpital Européen Georges-Pompidou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infracyanine in people with Breast Cancer, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 1 site 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 5 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: finished, as of the sponsor's last update on 5 Jul 2019. 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 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?
The primary endpoint is the SN detection rate during surgery by fluorescence, by isotopes, by combining the two. The detection rate is defined by the number of patient (time frame: During surgery). 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 NCT02875626, 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 5 Jul 2019.