Breast CancerNCT01880645
Selective Image Guided Resection of Axillary Lymph Nodes
A study testing Fine Needle Aspiration (FNA), Ultrasound and Breast Surgery + Lymph Node Removal in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if it is feasible to use find (using ultrasound) and surgically remove cancer that has spread to the lymph nodes, during routine lymph node surgery. In standard care, all affected lymph nodes are removed. 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?
- Fine Needle Aspiration (FNA), Ultrasound and Breast Surgery + Lymph Node Removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2015
- 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
- Greater than or equal to 18 years old.
- Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1 (maximum one or two abnormal axillary nodes on ultrasound exam) M0.
- FNA biopsy (or core needle biopsy) of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy or surgery.
- Marker clip placed in the one or two abnormal axillary nodes identified at ultrasound.
Who cannot join
- 1) Prior axillary lymph node surgery for pathological confirmation of axillary status.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Feasibility of Selective Image Guided Resection of Cytologically Documented Axillary Lymph Node Metastases
The goal of this clinical research study is to learn if it is feasible to use find (using ultrasound) and surgically remove cancer that has spread to the lymph nodes, during routine lymph node surgery.
In standard care, all affected lymph nodes are removed. In this study, however, the cancerous lymph nodes will be removed separately and then the rest of the lymph nodes under the arm will be removed after that.
Read the detailed description
Before surgery, patient may or may not receive the standard chemotherapy drug(s) that their doctor recommends. If patient's doctor suggests chemotherapy before surgery, they will be asked to sign a separate consent form that describes the chemotherapy and its risks.
On the day of surgery, patient will have an ultrasound of their lymph nodes. If patient has received chemotherapy before their surgery, they will have a fine needle aspiration (FNA) of any abnormal lymph nodes either right before or during their standard breast and underarm surgery. The abnormal lymph nodes will be marked for the surgeon to remove using standard techniques with either ultrasound, a mammogram, or 125I-seed placement. To perform an FNA, the area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected. Ultrasound imaging is used to guide the needle into the area. The cells will be used for research to learn if the chemotherapy killed the abnormal lymph node cells.
Patient will have standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction). Patient's doctor will discuss the surgery with patient in more detail and patient will be asked to sign a separate consent form.
During this surgery, the 1 or 2 abnormal underarm lymph nodes found by ultrasound will be removed and sent as separate samples before the rest of the underarm lymph nodes are removed.
Patient's study participation will be complete after surgery.
This is an investigational study. The surgery in this study is standard treatment. It is investigational to remove the abnormal lymph nodes before the rest of the underarm lymph nodes are removed. In this study, the exact same number of lymph nodes would be removed as is standard, but the surgery is being done in a 2-step process.
Up to 12 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- Fine Needle Aspiration (FNA), Ultrasound, Breast Surgery + Lymph Node Removal
- Keywords
- Breast Cancer, Invasive breast cancer, Axillary lymph node metastases, Ultrasound, Fine needle aspiration, FNA, Lymph node surgery, Partial mastectomy, Total mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine Needle Aspiration (FNA)Procedure or surgery
If patient received chemotherapy before surgery, fine needle aspiration (FNA) performed of any abnormal lymph nodes either right before or during standard breast and underarm surgery. To perform FNA, area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected.
UltrasoundProcedure or surgery
Patient receives an ultrasound of lymph nodes at diagnosis and on the day of surgery. Marker clip(s) placed using a needle in the abnormal lymph node(s).
Breast Surgery + Lymph Node RemovalProcedure or surgery
Patient receives standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction).
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound + Breast Surgery + Lymph Node Removal | Other | Patient receives an ultrasound of lymph nodes at diagnosis and on the day of surgery. Marker clip(s) placed using a needle in the abnormal lymph node(s). If patient received chemotherapy before surgery, fine needle aspiration (FNA) performed of any abnormal lymph nodes either right before or during standard breast and underarm surgery. To perform FNA, area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected. Standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction) performed. Receives: Procedure: Fine Needle Aspiration (FNA); Procedure: Ultrasound; Procedure: Breast Surgery + Lymph Node Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification of Axillary Node Metastases Using Ultrasound Imaging Before and After Guided Excision
Patients required to have a minimum of at least two nodal ultrasounds: once at diagnosis and once prior to surgery. Marker clip placed in the one or two abnormal node(s) at diagnosis and on day of surgery. Nodes localized by ultrasound (or by mammographic or 125I-seed localization if not visualized well with ultrasound) for excision, and fine needle aspiration (FNA) repeated of previous abnormal nodes. Patients undergo standard breast and axillary surgery. During surgery the one or two abnormal axillary nodes identified by ultrasound are removed. The lymph nodes excised with the clip will be evaluated with specimen x-ray. If no marker clip is identified in the lymph node(s), the axillary contents will be x-rayed to document removal of the marker clip. Procedure considered a success if all marker clips are successfully identified in the preoperative ultrasound and documented in a lymph node via postoperative specimen x-ray of the excised material.
Measured: 1 day
Secondary outcomes (1)
Absence of Residual Metastases
Secondary objective defined as determination of whether the excised node contains metastases or not (defined as a lymph node with a metastasis greater than 0.2 mm in greatest dimension identified by H\&E staining) and recording the presence or absence of residual metastases by repeat fine needle aspiration (FNA) at the time of surgery.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startMar 2012
- Primary completionSep 2015
- Study completionSep 2015
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.
- More trials run by M.D. Anderson 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henry Kuerer, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880645
- Sponsor's protocol ID
- 2012-0163
- Other IDs
- NCI-2014-02440
- Status last verified
- Nov 2015
- First submitted
- 12 Jun 2013
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Selective Image Guided Resection of Cytologically Documented Axillary Lymph Node Metastases
- ClinicalTrials.gov ID
- NCT01880645
- Acronym / sponsor ID
- 2012-0163
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Invasive breast cancer, Axillary lymph node metastases, Ultrasound, Fine needle aspiration, FNA, Lymph node surgery, Partial mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Jun 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 goal of this clinical research study is to learn if it is feasible to use find (using ultrasound) and surgically remove cancer that has spread to the lymph nodes, during routine lymph node surgery.
In standard care, all affected lymph nodes are removed. In this study, however, the cancerous lymph nodes will be removed separately and then the rest of the lymph nodes under the arm will be removed after that.
Detailed description
Before surgery, patient may or may not receive the standard chemotherapy drug(s) that their doctor recommends. If patient's doctor suggests chemotherapy before surgery, they will be asked to sign a separate consent form that describes the chemotherapy and its risks.
On the day of surgery, patient will have an ultrasound of their lymph nodes. If patient has received chemotherapy before their surgery, they will have a fine needle aspiration (FNA) of any abnormal lymph nodes either right before or during their standard breast and underarm surgery. The abnormal lymph nodes will be marked for the surgeon to remove using standard techniques with either ultrasound, a mammogram, or 125I-seed placement. To perform an FNA, the area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected. Ultrasound imaging is used to guide the needle into the area. The cells will be used for research to learn if the chemotherapy killed the abnormal lymph node cells.
Patient will have standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction). Patient's doctor will discuss the surgery with patient in more detail and patient will be asked to sign a separate consent form.
During this surgery, the 1 or 2 abnormal underarm lymph nodes found by ultrasound will be removed and sent as separate samples before the rest of the underarm lymph nodes are removed.
Patient's study participation will be complete after surgery.
This is an investigational study. The surgery in this study is standard treatment. It is investigational to remove the abnormal lymph nodes before the rest of the underarm lymph nodes are removed. In this study, the exact same number of lymph nodes would be removed as is standard, but the surgery is being done in a 2-step process.
Up to 12 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound + Breast Surgery + Lymph Node Removal | Other | Procedure: Fine Needle Aspiration (FNA), Procedure: Ultrasound, Procedure: Breast Surgery + Lymph Node RemovalPatient receives an ultrasound of lymph nodes at diagnosis and on the day of surgery. Marker clip(s) placed using a needle in the abnormal lymph node(s). If patient received chemotherapy before surgery, fine needle aspiration (FNA) performed of any abnormal lymph nodes either right before or during standard breast and underarm surgery. To perform FNA, area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected. Standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction) performed. |
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)
- Greater than or equal to 18 years old.
- Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1 (maximum one or two abnormal axillary nodes on ultrasound exam) M0.
- FNA biopsy (or core needle biopsy) of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy or surgery.
- Marker clip placed in the one or two abnormal axillary nodes identified at ultrasound.
Key exclusion criteria (1 listed)
- 1) Prior axillary lymph node surgery for pathological confirmation of axillary status.
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 |
|---|---|---|
| Fine Needle Aspiration (FNA)If patient received chemotherapy before surgery, fine needle aspiration (FNA) performed of any abnormal lymph nodes either right before or during standard breast and underarm surgery. To perform FNA, area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected. | Procedure or surgery | Ultrasound + Breast Surgery + Lymph Node Removal |
| UltrasoundPatient receives an ultrasound of lymph nodes at diagnosis and on the day of surgery. Marker clip(s) placed using a needle in the abnormal lymph node(s). | Procedure or surgery | Ultrasound + Breast Surgery + Lymph Node Removal |
| Breast Surgery + Lymph Node RemovalPatient receives standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction). | Procedure or surgery | Ultrasound + Breast Surgery + Lymph Node Removal |
Primary outcome
Verification of Axillary Node Metastases Using Ultrasound Imaging Before and After Guided Excision
Time frame: 1 day
Patients required to have a minimum of at least two nodal ultrasounds: once at diagnosis and once prior to surgery. Marker clip placed in the one or two abnormal node(s) at diagnosis and on day of surgery. Nodes localized by ultrasound (or by mammographic or 125I-seed localization if not visualized well with ultrasound) for excision, and fine needle aspiration (FNA) repeated of previous abnormal nodes. Patients undergo standard breast and axillary surgery. During surgery the one or two abnormal axillary nodes identified by ultrasound are removed. The lymph nodes excised with the clip will be evaluated with specimen x-ray. If no marker clip is identified in the lymph node(s), the axillary contents will be x-rayed to document removal of the marker clip. Procedure considered a success if all marker clips are successfully identified in the preoperative ultrasound and documented in a lymph node via postoperative specimen x-ray of the excised material.
1 secondary outcome
Absence of Residual Metastases
Time frame: 1 day
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 18 Nov 2015.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Henry Kuerer, MD,PHD principal investigator
M.D. Anderson 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 Fine Needle Aspiration (FNA), Ultrasound and Breast Surgery + Lymph Node Removal in people with Breast Cancer, run by M.D. Anderson 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 4 inclusion and 1 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 18 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?
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?
Verification of Axillary Node Metastases Using Ultrasound Imaging Before and After Guided Excision (time frame: 1 day). 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 18 Nov 2015.