Breast CancerPhase 2NCT01381315
Axillary Reverse Mapping
A Phase 2 study testing Injection of isotope and Axillary lymph node dissection in people with Breast Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND). 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?
- Injection of isotope and Axillary lymph node dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to May 2016
- Phase
- Phase 2
- 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
- 18 - 100 years old
- Not pregnant or breastfeeding
- Diagnosis of breast cancer requiring LN evaluation for ipsilateral or contralateral breast or prophylactic mastectomy
- Willing participation after obtaining informed consent
Who cannot join
- < 18 or > 100 years of age
- Pregnant or breastfeeding
- Blue dye allergy
- Cosmetic allergy
- History of primary lymphedema
- Prior breast augmentation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: ARM: Axillary Reverse Mapping
It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND). Therefore, mapping the drainage of the arm in addition to the drainage of the breast during the procedure would potentially decrease the incidence of arm lymphatic disruption and subsequent development of lymphedema while providing adequate axillary breast nodes needed for staging.
Read the detailed description
Patients will receive an injection of 1.0 mCi of technetium-99m sulfur colloid that will be injected into the sub-dermal subareolar aspect of the affected breast.
On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur < 3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in any of the above mentioned scenarios. The site of all injections (radioactivity and/or blue dye) will be recorded.
- Conditions
- Breast Cancer
- Being tested
- Injection of isotope, Axillary lymph node dissection
- Keywords
- Sentinel lymph node biopsy, Axillary lymph node dissection, Prevention of lymphedema
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of isotopeProcedure or surgery
On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur <3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in any of the above mentioned scenarios.
Axillary lymph node dissectionProcedure or surgery
The one-year lymphedema rate among subjects undergoing axillary lymph node dissection with or without sentinel lymph node biopsy is ≥ 0.13. With our sample size of 58 subjects undergoing ALND, we will reject that hypothesis in favor of the alternative-that the lymphedema rate is <0.13 for subjects undergoing ALND-if lymphedema is confirmed in three or fewer (ie, 0, 1, 2, or 3) subjects.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel lymph node biopsy | Other | During surgery, 1.0 mCi of technetium-99m sulfur colloid will be injected into sub-dermal subareolar aspect of the affected breast. The KUMC Nuclear Medicine Department will be responsible for performing the injection of the isotope and dilution of the isotope using saline to a final volume of 4.0 ml or less. Receives: Procedure: Injection of isotope |
| Axillary lymph node biopsy | Other | Not described Receives: Procedure: Axillary lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess lymphedema rates
The primary objective of this study is to assess and test the lymphedema rates six times at the following intervals: Pre-surgery - baseline, at 6 months, and yearly for 4 years. Since the historical control rates are different (5% for SLNB only and 13% for ALND with or without SLNB) two tests will be performed.
Measured: Four Years
Secondary outcomes (4)
Identification of breast sentinal lymph node and arm lymphatics
Successful identification (localization) of breast sentinel lymph node and arm lymphatics
Measured: at time of surgery
Characterization of location
Characterization of location (typical versus variant) of arm lymphatics
Measured: at time of surgery
Protection of the arm
Successful protection of the arm lymphatics during sentinel lymph node biopsy and/or axillary lymph node dissection
Measured: at time of surgery
Occurrence of crossover
Occurrence of crossover (i.e., co-localization) between hot breast sentinel lymph node and blue arm lymphatics
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startSep 2009
- Primary completionMay 2016
- Study completionMay 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie Wagner, DO, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381315
- Sponsor's protocol ID
- 11737
- Status last verified
- Jan 2017
- First submitted
- 9 Jun 2011
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARM: Axillary Reverse Mapping
- ClinicalTrials.gov ID
- NCT01381315
- Acronym / sponsor ID
- 11737
- Conditions
- Breast Cancer
- Keywords
- Sentinel lymph node biopsy, Axillary lymph node dissection, Prevention of lymphedema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Jun 2011 (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.
It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND). Therefore, mapping the drainage of the arm in addition to the drainage of the breast during the procedure would potentially decrease the incidence of arm lymphatic disruption and subsequent development of lymphedema while providing adequate axillary breast nodes needed for staging.
Detailed description
Patients will receive an injection of 1.0 mCi of technetium-99m sulfur colloid that will be injected into the sub-dermal subareolar aspect of the affected breast.
On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur < 3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in any of the above mentioned scenarios. The site of all injections (radioactivity and/or blue dye) will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel lymph node biopsy | Other | Procedure: Injection of isotopeDuring surgery, 1.0 mCi of technetium-99m sulfur colloid will be injected into sub-dermal subareolar aspect of the affected breast. The KUMC Nuclear Medicine Department will be responsible for performing the injection of the isotope and dilution of the isotope using saline to a final volume of 4.0 ml or less. |
| Axillary lymph node biopsy | Other | Procedure: Axillary lymph node dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 100 years old
- Not pregnant or breastfeeding
- Diagnosis of breast cancer requiring LN evaluation for ipsilateral or contralateral breast or prophylactic mastectomy
- Willing participation after obtaining informed consent
Key exclusion criteria (6 listed)
- < 18 or > 100 years of age
- Pregnant or breastfeeding
- Blue dye allergy
- Cosmetic allergy
- History of primary lymphedema
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 |
|---|---|---|
| Injection of isotopeOn the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur <3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in any of the above mentioned scenarios. | Procedure or surgery | Sentinel lymph node biopsy |
| Axillary lymph node dissectionThe one-year lymphedema rate among subjects undergoing axillary lymph node dissection with or without sentinel lymph node biopsy is ≥ 0.13. With our sample size of 58 subjects undergoing ALND, we will reject that hypothesis in favor of the alternative-that the lymphedema rate is <0.13 for subjects undergoing ALND-if lymphedema is confirmed in three or fewer (ie, 0, 1, 2, or 3) subjects. | Procedure or surgery | Axillary lymph node biopsy |
Primary outcome
Assess lymphedema rates
Time frame: Four Years
The primary objective of this study is to assess and test the lymphedema rates six times at the following intervals: Pre-surgery - baseline, at 6 months, and yearly for 4 years. Since the historical control rates are different (5% for SLNB only and 13% for ALND with or without SLNB) two tests will be performed.
4 secondary outcomes
Identification of breast sentinal lymph node and arm lymphatics
Time frame: at time of surgery
Characterization of location
Time frame: at time of surgery
Protection of the arm
Time frame: at time of surgery
Occurrence of crossover
Time frame: at time of surgery
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 10 Jan 2017.
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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.
Jamie Wagner, DO principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Injection of isotope and Axillary lymph node dissection in people with Breast Cancer, run by University of Kansas Medical 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 4 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 10 Jan 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Assess lymphedema rates (time frame: Four 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 10 Jan 2017.