BREAST CANCERSENTIMAGNCT01790399
IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER
A study testing Excision of sentinel node(s) in people with BREAST CANCER, run by Centre Oscar Lambret at 4 sites in France.
Trial summary
The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product). This is a feasibility study 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?
- Excision of sentinel node(s)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 4 sitesFrance
- Study dates
- Jan 2013to Jul 2014
- 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
- Patient with invasive breast cancer or microinfiltrant proven by cytology and histo-or whatever the histological type
- cT0/cT1/cT2 (up to 5 cm) CN0 clinical and / or ultrasound and without prior treatment (chemotherapy or neoadjuvant hormone )
- Age greater than or equal to 18
- Reporting of breast surgery and axillary staging of sentinel lymph node
- Using effective contraception (BHCG negative)
- Patient affiliated with a health insurance
- Consent signed by the patient
Who cannot join
- T3 or T4 tumors (> 5 cm, cutaneous or muscle inflammation or cancer)
- Presence of a clinically suspicious axillary adenopathy or imaging
- Tumors bifocal or multifocal known before Surgery
- History of breast surgery or axillary
- Patient metastatic
- Patient with a cons-indication anesthesia and / or surgery
Show all 14Show fewer
- Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to Patent blue dye in centers where it is commonly used
- Patient can not receive a radioactive isotope to the sentinel lymph node resection
- Allergy radioactive product
- Chronic iron overload
- Pacemaker or other implantable device in the chest wall
- Failure to submit to medical study for geographical, social or psychological
- Patient deprived of liberty or under guardianship
- Pregnant or lactating
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Oscar Lambret
Lille, 59020
Centre Eugène Marquis
Rennes, 35042
Institut Claudius Regaud
Toulouse, 31 052
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54 511
About this study
Official title: IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY
The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product). This is a feasibility study
Read the detailed description
- Identification of Sentinel node(s)
- Step 1: Identification using the technique Nanocis Sub-areolar injection of Tc99m-Nanocis ® the day before or the day of surgery
- Step 2: Identification using the technique SentiMag ® / Sienna+ Injection Sienna + ™ should be done just after induction of anesthesia and before the injection of Patent Blue dye
- Step 3: Identification using the technique of Patent Blue Dye or Lymphotropic dye injection or Patent Blue is performed after induction of anesthesia, the injection and production Sienna + ™, the operating theater by the surgeon
- Detection of Sentinel node(s)
- Step 1: probe SentiMag ® (study)
- Step 2: hand probe gamma radiation detection and / or colorimetric detection (standard)
- Sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown)
- After the procedure:
Characterization of the size and weight of lymph nodes, histological and / or molecular OSNA and linking nodal status with the detection rate of sentinel nodes for each technique.
NB: In case of synchronous bilateral cancer, 2 records are possible
- Conditions
- BREAST CANCER
- Being tested
- Excision of sentinel node(s)
- Keywords
- SENTINEL NODE
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision of sentinel node(s)Procedure or surgery
Excision of sentinel node(s) using SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product)
| Study group | Role | What they receive |
|---|---|---|
| Identification of sentinel node(s) | Experimental | Not described Receives: Procedure: Excision of sentinel node(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel node(s)detected with new technical
Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM)
Measured: The day of surgery
Secondary outcomes (1)
Detected node(s) for each method(standard and new)
Proportion of detected nodes for each method(standard and new)
Measured: The day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionJul 2014 (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.
- 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
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Sysmex America, Inc.
- Responsible party
- Sponsor
- Investigators
- Jean-Louis MD HOUPEAU, Study director, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790399
- Sponsor's protocol ID
- SENTIMAG-1213
- Acronym
- SENTIMAG
- Status last verified
- Aug 2013
- First submitted
- 8 Feb 2013
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY
- ClinicalTrials.gov ID
- NCT01790399
- Acronym / sponsor ID
- SENTIMAG / SENTIMAG-1213
- Conditions
- BREAST CANCER
- Keywords
- SENTINEL NODE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Sysmex America, Inc.
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 13 Feb 2013 (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.
The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product). This is a feasibility study
Detailed description
- Identification of Sentinel node(s)
- Step 1: Identification using the technique Nanocis Sub-areolar injection of Tc99m-Nanocis ® the day before or the day of surgery
- Step 2: Identification using the technique SentiMag ® / Sienna+ Injection Sienna + ™ should be done just after induction of anesthesia and before the injection of Patent Blue dye
- Step 3: Identification using the technique of Patent Blue Dye or Lymphotropic dye injection or Patent Blue is performed after induction of anesthesia, the injection and production Sienna + ™, the operating theater by the surgeon
- Detection of Sentinel node(s)
- Step 1: probe SentiMag ® (study)
- Step 2: hand probe gamma radiation detection and / or colorimetric detection (standard)
- Sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown)
- After the procedure:
Characterization of the size and weight of lymph nodes, histological and / or molecular OSNA and linking nodal status with the detection rate of sentinel nodes for each technique.
NB: In case of synchronous bilateral cancer, 2 records are possible
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Identification of sentinel node(s) | Experimental | Procedure: Excision of sentinel node(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with invasive breast cancer or microinfiltrant proven by cytology and histo-or whatever the histological type
- cT0/cT1/cT2 (up to 5 cm) CN0 clinical and / or ultrasound and without prior treatment (chemotherapy or neoadjuvant hormone )
- Age greater than or equal to 18
- Reporting of breast surgery and axillary staging of sentinel lymph node
- Using effective contraception (BHCG negative)
Key exclusion criteria (14 listed)
- T3 or T4 tumors (> 5 cm, cutaneous or muscle inflammation or cancer)
- Presence of a clinically suspicious axillary adenopathy or imaging
- Tumors bifocal or multifocal known before Surgery
- History of breast surgery or axillary
- Patient metastatic
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 |
|---|---|---|
| Excision of sentinel node(s)Excision of sentinel node(s) using SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product) | Procedure or surgery | Identification of sentinel node(s) |
Primary outcome
Sentinel node(s)detected with new technical
Time frame: The day of surgery
Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM)
1 secondary outcome
Detected node(s) for each method(standard and new)
Time frame: The day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
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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.
Jean-Louis MD HOUPEAU study director
Centre Oscar Lambret
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excision of sentinel node(s) in people with BREAST CANCER, run by Centre Oscar Lambret at 4 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 7 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 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
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?
Sentinel node(s)detected with new technical (time frame: The day 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 6 Mar 2014.