Breast CancerNCT00717886
Upper Extremity Lymphatic Mapping for Breast Cancer Patients
A study testing isosulfan blue dye in people with Breast Cancer and Axillary Lymph Node Dissection, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Axillary Lymph Node Dissection
- What is being tested?
- isosulfan blue dye
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Oct 2009
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND.
- Females > 21 years of age
Who cannot join
- Prior ipsilateral axillary surgery
- Prior ipsilateral axillary radiation
- Prior ipsilateral breast cancer
- Prior ipsilateral breast radiation
- Allergy to isosulfan blue dye
- History of ipsilateral upper extremity lymphedema
Show all 9Show fewer
- Prior history of surgical excision of the upper outer quadrant of the ipsilateral breast
- Prior history of neoadjuvant chemotherapy for current breast cancer
- Bulky axillary disease at presentation (N2)
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study
This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. They are then examined to see if they have cancer cells. Removing these lymph nodes has some side effects. The most common is lymphedema. This is the build-up of fluid in the arm. This study will tell us if it may be possible in the future to identify lymph nodes that just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future patients.
- Conditions
- Breast Cancer, Axillary Lymph Node Dissection
- Being tested
- isosulfan blue dye
- Keywords
- Breast, Lymph Nodes
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isosulfan blue dyeRadiation
Also called Once the specimen is removed from the patient, the axillary nodes will be, dissected from the specimen and categorized: "blue only"; "radioactive only";, "blue and radioactive"; and "neither." The number of axillary nodes which are, "radioactive only" will indicate the nodes which drain the ipsilateral upper
At the time of surgery, each patient will undergo a subareolar injection of isosulfan blue dye into the ipsilateral breast as routinely performed during a sentinel lymph node mapping for breast cancer. The surgeon will then perform an axillary lymph node dissection in the usual, routine manner. The above differs from standard of care in that patients scheduled for an upfront axillary dissection do not routinely undergo sentinel lymph node mapping- therefore these patients would not normally get any isotope or TSC injections since they already need an ALND. Second, standard sentinel lymph node mapping involves injection of TSC into the affected breast the day prior to surgery or 3 hours before surgery versus injection of TSC into the ipsilateral upper extremity. The protocol specifies "day of" mapping for patient convenience.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery. Receives: Radiation: isosulfan blue dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2009
- Study completionOct 2009
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 CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Montgomery, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717886
- Sponsor's protocol ID
- 08-051
- Status last verified
- Oct 2015
- First submitted
- 16 Jul 2008
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT00717886
- Acronym / sponsor ID
- 08-051
- Conditions
- Breast Cancer, Axillary Lymph Node Dissection
- Keywords
- Breast, Lymph Nodes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Posted 20 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. They are then examined to see if they have cancer cells. Removing these lymph nodes has some side effects. The most common is lymphedema. This is the build-up of fluid in the arm. This study will tell us if it may be possible in the future to identify lymph nodes that just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: isosulfan blue dyePatients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND.
- Females > 21 years of age
Key exclusion criteria (9 listed)
- Prior ipsilateral axillary surgery
- Prior ipsilateral axillary radiation
- Prior ipsilateral breast cancer
- Prior ipsilateral breast radiation
- Allergy to isosulfan blue dye
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 blue dyeAlso: Once the specimen is removed from the patient, the axillary nodes will be, dissected from the specimen and categorized: "blue only"; "radioactive only";, "blue and radioactive"; and "neither." The number of axillary nodes which are, "radioactive only" will indicate the nodes which drain the ipsilateral upperAt the time of surgery, each patient will undergo a subareolar injection of isosulfan blue dye into the ipsilateral breast as routinely performed during a sentinel lymph node mapping for breast cancer. The surgeon will then perform an axillary lymph node dissection in the usual, routine manner. The above differs from standard of care in that patients scheduled for an upfront axillary dissection do not routinely undergo sentinel lymph node mapping- therefore these patients would not normally get any isotope or TSC injections since they already need an ALND. Second, standard sentinel lymph node mapping involves injection of TSC into the affected breast the day prior to surgery or 3 hours before surgery versus injection of TSC into the ipsilateral upper extremity. The protocol specifies "day of" mapping for patient convenience. | Radiation | 1 |
Primary outcome
Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Leslie Montgomery, MD principal investigator
Memorial Sloan Kettering 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 dye in people with Breast Cancer and Axillary Lymph Node Dissection, run by Memorial Sloan Kettering Cancer Center 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?
The sponsor lists 2 inclusion and 9 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 20 Nov 2015. 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 20 Nov 2015). 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 and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast). (time frame: 2 years). 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 20 Nov 2015.