Breast NeoplasmsPhase 3FLUOTECHNCT02279108
Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
A Phase 3 study testing indocyanine green and isotope in people with Breast Neoplasms, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The sentinel node has a fundamental role in the management of early breast cancer. Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- indocyanine green and isotope
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Jul 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…)
- Unifocal or multifocal but in same quarter
- Size < 5cm clinically palpable or not
- Clinically or ultrasound axillary N0
- Isotopic sentinel node detection
- Adult patient
Show all 9Show fewer
- Signed informed consent by patient or legally responsable authority
- Patient registered to a social security system
- No surgical contra-indication
Who cannot join
- Mammary carcinoma recurrence
- Previous same side mammary reduction
- Previous lumpectomy
- Contra-indication to surgery
- Pregnant or breast feeding patient
- Denial of participation
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Comparative, Prospective, Randomized Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
The sentinel node has a fundamental role in the management of early breast cancer.
Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice.
Read more
So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough.
Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable.
The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.
- Conditions
- Breast Neoplasms
- Being tested
- indocyanine green, isotope
- Keywords
- sentinel lymph node, indocyanine green, fluorescence method, radioisotope conventional method, breast cancer
- 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
One injection, 2.5 milligrams per patient, intradermal use
isotopeDrug
Also called technetium
One injection, 20 MBq techntium99, intradermal use
| Study group | Role | What they receive |
|---|---|---|
| double detection Indocyanine + isotope | Experimental | intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery Receives: Drug: indocyanine green; Drug: isotope |
| isotope detection alone | Active comparator | intradermal injection of 20 MBq of technetium 99 before breast surgery Receives: Drug: isotope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Less Than Two Lymph Nodes Detected
Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone
Measured: peroperative
Secondary outcomes (10)
Number of Lymph Nodes ICG Positive and Tc Positive
Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive
Measured: Peroperative
Number of Lymph Nodes ICG Positive and Tc Negative
Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative
Measured: Peroperative
Number of Lymph Nodes ICG Negative and Tc Positive
Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive
Measured: Peroperative
Comparison Between Groups of the Time of the Surgery
time from incision to wound closure
Measured: Peroperative
Comparison Between Groups of Anesthesia Time
time from the injection of anesthesic to the waking
Measured: Peroperative
Time From Injection of One Dose ICG Injection to Incision Time
time from injection of one dose ICG injection to incision time
Measured: Peroperative
Comparison Between Groups of Time Surgery Node
time from incision time to the last node surgery
Measured: Peroperative
Number of Patients With ICG Allergy
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Measured: peroperative
Number of Patients With ICG Allergy
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Measured: 1 hour after the end of the surgery
Number of Patients With ICG Allergy
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline CHAULEUR, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279108
- Sponsor's protocol ID
- 1408153
- Other IDs
- 2014-004005-32, 2014
- Acronym
- FLUOTECH
- Status last verified
- Sep 2017
- First submitted
- 27 Oct 2014
- Last updated
- 9 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Prospective, Randomized Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT02279108
- Acronym / sponsor ID
- FLUOTECH / 1408153
- Conditions
- Breast Neoplasms
- Keywords
- sentinel lymph node, indocyanine green, fluorescence method, radioisotope conventional method, breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Posted 9 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The sentinel node has a fundamental role in the management of early breast cancer.
Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice.
So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough.
Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable.
The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double detection Indocyanine + isotope | Experimental | Drug: indocyanine green, Drug: isotopeintradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery |
| isotope detection alone | Active comparator | Drug: isotopeintradermal injection of 20 MBq of technetium 99 before breast surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…)
- Unifocal or multifocal but in same quarter
- Size < 5cm clinically palpable or not
- Clinically or ultrasound axillary N0
- Isotopic sentinel node detection
Key exclusion criteria (6 listed)
- Mammary carcinoma recurrence
- Previous same side mammary reduction
- Previous lumpectomy
- Contra-indication to surgery
- Pregnant or breast feeding patient
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 greenOne injection, 2.5 milligrams per patient, intradermal use | Drug | double detection Indocyanine + isotope |
| isotopeAlso: technetiumOne injection, 20 MBq techntium99, intradermal use | Drug | double detection Indocyanine + isotope, isotope detection alone |
Primary outcome
Number of Patients With Less Than Two Lymph Nodes Detected
Time frame: peroperative
Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone
10 secondary outcomes
Number of Lymph Nodes ICG Positive and Tc Positive
Time frame: Peroperative
Number of Lymph Nodes ICG Positive and Tc Negative
Time frame: Peroperative
Number of Lymph Nodes ICG Negative and Tc Positive
Time frame: Peroperative
Comparison Between Groups of the Time of the Surgery
Time frame: Peroperative
Comparison Between Groups of Anesthesia Time
Time frame: Peroperative
Time From Injection of One Dose ICG Injection to Incision Time
Time frame: Peroperative
Comparison Between Groups of Time Surgery Node
Time frame: Peroperative
Number of Patients With ICG Allergy
Time frame: peroperative
Number of Patients With ICG Allergy
Time frame: 1 hour after the end of the surgery
Number of Patients With ICG Allergy
Time frame: Month 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Céline CHAULEUR, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing indocyanine green and isotope in people with Breast Neoplasms, run by Centre Hospitalier Universitaire de Saint Etienne 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 9 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 9 Apr 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Less Than Two Lymph Nodes Detected (time frame: peroperative). 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 9 Apr 2018.