Breast CancerNCT00052676
Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer
A study testing patent blue V dye, radionuclide imaging and sentinel lymph node biopsy in people with Breast Cancer, run by Centre Paul Strauss at 7 sites in France.
Trial summary
RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer. 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?
- patent blue V dye, radionuclide imaging and sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 7 sitesFrance
- Study dates
- Oct 2002to May 2007
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed invasive breast cancer
- T0, T1, or T2 no greater than 3 cm, N0
- Amenable to surgery
- No inflammatory breast cancer
- No ductal cancer in situ or multicentric invasive ductal cancer
- No nipple/areola or central breast cancer (at least 2 cm from areola)
- No metastatic disease
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- Over 18
Sex
- Not specified
Menopausal status
- Not specified
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant
- Negative pregnancy test
- No known allergy or intolerance to patent blue V dye
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- No prior surgery for cancer
Other
- No prior neoadjuvant treatment for cancer
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Clinique Tivoli
Bordeaux, F-33030
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Leon Berard
Lyon, 69373
Institut J. Paoli and I. Calmettes
Marseille, 13273
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, 44805
Centre Paul Strauss
Strasbourg, 67085
Institut Claudius Regaud
Strasbourg, 67085
About this study
Official title: French Randomized Sentinel Node Multicentric Study
RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer.
PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the optimal mode of injection (peritumoral vs periareolar) of patent blue V dye and technetium Tc 99m sulfur colloid in patients with stage I or II breast cancer undergoing sentinel lymph node identification.
- Determine the reduction of morbidity associated with breast cancer surgery, in terms of local control and survival, in patients undergoing sentinel lymph node identification with these drugs.
- Determine the evolution of disease in patients who have undergone this procedure and do not show histological invasion of the sentinel lymph node.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive peritumoral injections of patent blue V dye and technetium Tc 99m sulfur colloid.
- Arm II: Patients receive periareolar injections as in arm I. Patients in both arms showing histological metastasis of the sentinel lymph node or without identification of the sentinel lymph node undergo standard axillary lymph node dissection.
Patients are followed for disease evolution.
PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 2-2.5 years.
- Conditions
- Breast Cancer
- Being tested
- patent blue V dye, radionuclide imaging, sentinel lymph node biopsy, technetium Tc 99m sulfur colloid
- Keywords
- stage I breast cancer, stage II 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.
patent blue V dyeDrug
radionuclide imagingProcedure or surgery
sentinel lymph node biopsyProcedure or surgery
technetium Tc 99m sulfur colloidRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2002
- Study completionMay 2007
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
- Randomised
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Francois Rodier, MD, Study chair, Centre Paul Strauss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052676
- Sponsor's protocol ID
- STRAUSS-FRANSENOD
- Other IDs
- CDR0000258612, EU-20214
- Status last verified
- Sep 2007
- First submitted
- 24 Jan 2003
- Last updated
- 15 May 2013
- Results posted
- No
Publications
Rodier JF, Velten M, Wilt M, Martel P, Ferron G, Vaini-Elies V, Mignotte H, Bremond A, Classe JM, Dravet F, Routiot T, de Lara CT, Avril A, Lorimier G, Fondrinier E, Houvenaeghel G, Avigdor S. Prospective multicentric randomized study comparing periareolar and peritumoral injection of radiotracer and blue dye for the detection of sentinel lymph node in breast sparing procedures: FRANSENODE trial. J Clin Oncol. 2007 Aug 20;25(24):3664-9. doi: 10.1200/JCO.2006.08.4228. Epub 2007 May 7.
PubMed 17485709
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Randomized Sentinel Node Multicentric Study
- ClinicalTrials.gov ID
- NCT00052676
- Acronym / sponsor ID
- STRAUSS-FRANSENOD
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- May 2007 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer.
PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.
Detailed description
OBJECTIVES:
- Determine the optimal mode of injection (peritumoral vs periareolar) of patent blue V dye and technetium Tc 99m sulfur colloid in patients with stage I or II breast cancer undergoing sentinel lymph node identification.
- Determine the reduction of morbidity associated with breast cancer surgery, in terms of local control and survival, in patients undergoing sentinel lymph node identification with these drugs.
- Determine the evolution of disease in patients who have undergone this procedure and do not show histological invasion of the sentinel lymph node.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive peritumoral injections of patent blue V dye and technetium Tc 99m sulfur colloid.
- Arm II: Patients receive periareolar injections as in arm I. Patients in both arms showing histological metastasis of the sentinel lymph node or without identification of the sentinel lymph node undergo standard axillary lymph node dissection.
Patients are followed for disease evolution.
PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 2-2.5 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| patent blue V dye | Drug | – |
| radionuclide imaging | Procedure or surgery | – |
| sentinel lymph node biopsy | Procedure or surgery | – |
| technetium Tc 99m sulfur colloid | Radiation | – |
Primary outcome
Not reported in the source record.
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 15 May 2013.
- Results publication: PubMed 17485709Rodier JF, Velten M, Wilt M, Martel P, Ferron G, Vaini-Elies V, Mignotte H, Bremond A, Classe JM, Dravet F, Routiot T, de Lara CT, Avril A, Lorimier G, Fondrinier E, Houvenaeghel G, Avigdor S. Prospective multicentric randomized study comparing periareolar and peritumoral injection of radiotracer and blue dye for the detection of sentinel lymph node in breast sparing procedures: FRANSENODE trial. J Clin Oncol. 2007 Aug 20;25(24):3664-9. doi: 10.1200/JCO.2006.08.4228. Epub 2007 May 7.
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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-Francois Rodier, MD study chair
Centre Paul Strauss
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patent blue V dye, radionuclide imaging and sentinel lymph node biopsy in people with Breast Cancer, run by Centre Paul Strauss at 7 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?
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 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00052676, 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 15 May 2013; AzTrials last refreshed its copy on 6 Nov 2026.