Breast CancerNCT00450723
Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer
A study testing Isosulfan blue, Axillary Lymph Node Dissection and Surgery in people with Breast Cancer, run by University of Miami at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Isosulfan blue, Axillary Lymph Node Dissection and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Mar 2011
- Phase
- Interventional
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Stage I or II disease (T1-T2, N0, M0/MX disease)
- No chest wall invasion by tumor (T3 disease)
- Medially or centrally located lesion
- No multicentric disease
- Multifocal disease allowed
- No clinically positive axillary nodes
- No enlarged internal mammary nodes by CT scan
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Male or female
- Menopausal status not specified
- American Society of Anesthesiologists (ASA) physical status classification 1-2
- Not pregnant or nursing
- Negative pregnancy test
- No other concurrent known, invasive malignancy
- No known chronic pulmonary disease
- No known allergy to methylene blue or isosulfan blue
PRIOR CONCURRENT THERAPY:
- No prior thoracic or cardiac surgery
- No prior ipsilateral chest tube placement
- Contralateral chest tube placement allowed
- No prior neoadjuvant chemotherapy
- No prior radiotherapy to the mediastinum
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
About this study
Official title: Thoracoscopic Internal Mammary Sentinel Node Biopsy
RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment.
PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage I or II breast cancer.
- Determine the safety, feasibility, and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients.
- Determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients.
OUTLINE: Patients undergo standard axillary sentinel lymph node dissection during surgery (i.e., lumpectomy or mastectomy). Patients receive a radioactive tracer (i.e., technetium Tc 99m sulfur colloid) and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes (IMSLN). Identified axillary sentinel lymph nodes are dissected. Identified IMSLNs are removed through the lumpectomy/mastectomy incision, if accessible. If they are not accessible, patients undergo thorascopic IMSLN biopsy to remove the nodes.
All removed sentinel lymph nodes (axillary or internal mammary) are examined for gross and microscopic carcinoma for future therapy planning.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- Isosulfan blue, Axillary Lymph Node Dissection, Surgery, Sentinel Lymph Node Biopsy, Thoracoscopic Surgery
- Keywords
- stage I breast cancer, stage II breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosulfan blueDrug
Also called Lymphazurin
Administered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure.
Axillary Lymph Node DissectionProcedure or surgery
Axillary Lymph Node Dissection
SurgeryProcedure or surgery
The surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest.
Sentinel Lymph Node BiopsyProcedure or surgery
Sentinel Lymph Node Biopsy
Thoracoscopic SurgeryProcedure or surgery
Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.
Technetium Tc 99m Sulfur ColloidRadiation
Two to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Lymph Node Biopsy | Experimental | Not described Receives: Drug: Isosulfan blue; Procedure: Axillary Lymph Node Dissection; Procedure: Surgery; Procedure: Sentinel Lymph Node Biopsy; Procedure: Thoracoscopic Surgery; Radiation: Technetium Tc 99m Sulfur Colloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy
Measured: 5 years
Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes
Measured: 5 years
Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startMay 2004
- Primary completionJan 2011
- Study completionMar 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eli Avisar, MD, Study chair, University of Miami Sylvester Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450723
- Sponsor's protocol ID
- 20040015
- Other IDs
- SCCC-2003161, WIRB-20050911
- Status last verified
- Dec 2016
- First submitted
- 20 Mar 2007
- Last updated
- 7 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Avisar E, Molina MA, Scarlata M, Moffat FL. Internal mammary sentinel node biopsy for breast cancer. Am J Surg. 2008 Oct;196(4):490-4. doi: 10.1016/j.amjsurg.2008.06.003. Epub 2008 Aug 23.
PubMed 18723148
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopic Internal Mammary Sentinel Node Biopsy
- ClinicalTrials.gov ID
- NCT00450723
- Acronym / sponsor ID
- 20040015
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, male breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Mar 2007 (estimated)
- Results
- Posted 5 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment.
PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.
Detailed description
OBJECTIVES:
- Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage I or II breast cancer.
- Determine the safety, feasibility, and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients.
- Determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients.
OUTLINE: Patients undergo standard axillary sentinel lymph node dissection during surgery (i.e., lumpectomy or mastectomy). Patients receive a radioactive tracer (i.e., technetium Tc 99m sulfur colloid) and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes (IMSLN). Identified axillary sentinel lymph nodes are dissected. Identified IMSLNs are removed through the lumpectomy/mastectomy incision, if accessible. If they are not accessible, patients undergo thorascopic IMSLN biopsy to remove the nodes.
All removed sentinel lymph nodes (axillary or internal mammary) are examined for gross and microscopic carcinoma for future therapy planning.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentinel Lymph Node Biopsy | Experimental | Drug: Isosulfan blue, Procedure: Axillary Lymph Node Dissection, Procedure: Surgery, Procedure: Sentinel Lymph Node Biopsy, Procedure: Thoracoscopic Surgery, Radiation: Technetium Tc 99m Sulfur Colloid |
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| Isosulfan blueAlso: LymphazurinAdministered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure. | Drug | Sentinel Lymph Node Biopsy |
| Axillary Lymph Node DissectionAxillary Lymph Node Dissection | Procedure or surgery | Sentinel Lymph Node Biopsy |
| SurgeryThe surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest. | Procedure or surgery | Sentinel Lymph Node Biopsy |
| Sentinel Lymph Node BiopsySentinel Lymph Node Biopsy | Procedure or surgery | Sentinel Lymph Node Biopsy |
| Thoracoscopic SurgeryPerformed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy. | Procedure or surgery | Sentinel Lymph Node Biopsy |
| Technetium Tc 99m Sulfur ColloidTwo to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots | Radiation | Sentinel Lymph Node Biopsy |
Primary outcome
Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy
Time frame: 5 years
Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes
Time frame: 5 years
Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18723148Avisar E, Molina MA, Scarlata M, Moffat FL. Internal mammary sentinel node biopsy for breast cancer. Am J Surg. 2008 Oct;196(4):490-4. doi: 10.1016/j.amjsurg.2008.06.003. Epub 2008 Aug 23.
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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.
Eli Avisar, MD study chair
University of Miami Sylvester Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isosulfan blue, Axillary Lymph Node Dissection and Surgery in people with Breast Cancer, run by University of Miami at 1 site in United States.
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 7 Feb 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Apr 2013). 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?
Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy (time frame: 5 years). The study lists 3 primary outcomes in all. 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 NCT00450723, 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 7 Feb 2017.