Breast NeoplasmEarly Phase 1NCT02610920
Sentinel Lymph Node Identification in the Axilla of Women With Breast Cancer Using Ultrasound and Iron Injection
A Early Phase 1 study testing Iron-tracer guided axillary ultrasound and biopsy and Iron tracer in people with Breast Neoplasm and Carcinoma, Ductal, Breast, run by Columbia University.
Trial summary
This study evaluates a new method of testing the lymph nodes in the armpit of patients with breast cancer for tumor involvement. All participants involved in this study will undergo an injection of a small amount of iron dissolved in liquid followed by an ultrasound of the axilla that will make previously invisible… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm, Carcinoma, Ductal, Breast, Carcinoma, Intraductal, Noninfiltrating
- What is being tested?
- Iron-tracer guided axillary ultrasound and biopsy and Iron tracer
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jan 2018
- Phase
- Early Phase 1
- 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
- Female patients at least 21 years old
- Patients with invasive ductal carcinoma staged T1 or T2 with estrogen receptor and progesterone receptor positive (ER+/PR+) who are scheduled for sentinel lymph node biopsy
- Patients with Ductal Carcinoma In Situ (DCIS) (high or low grade) who are scheduled for sentinel lymph node biopsy including:
- Patients having a mastectomy
- Patients with palpable DCIS
- Patients undergoing breast conservation with large (>5cm) area of DCIS
- Patients with signed consent to participate
Who cannot join
- Preoperative palpable axillary lymphadenopathy
- Preoperative ultrasound demonstrating suspicious adenopathy
- Previous axillary dissection or previous lymph node biopsy
- Patients with Invasive Lobular Carcinoma
- Patients who are pregnant
About this study
Official title: Identification of Sentinel Lymph Nodes by Ultrasound Utilizing Iron Tracer Injection and Preoperative Biopsy in Women With Breast Cancer
This study evaluates a new method of testing the lymph nodes in the armpit of patients with breast cancer for tumor involvement. All participants involved in this study will undergo an injection of a small amount of iron dissolved in liquid followed by an ultrasound of the axilla that will make previously invisible lymph nodes visible, allowing them to be sampled in an outpatient setting.
Read the detailed description
Lymph nodes are small collections of tissue all over the body that drain bodily fluid. These axillary lymph nodes are important in evaluating breast cancer since, if they are positive, it suggests that the cancer cells have spread outside of the breast. The current standard of care is for most breast cancer patients undergoing surgery to have a sentinel lymph node biopsy which is a procedure to take a sample of the lymph nodes in the armpit (also called the axilla) during their breast surgery. However this intraoperative biopsy comes with certain risks such as arm swelling or lymphedema, arm pain, arm numbness/tingling, and/or psychological distress from waiting for the results or the possibility of further interventions. In order to avoid this and have a result before surgery, this study will explore a nonsurgical method of sampling these lymph nodes. Normally suspicious lymph nodes are hard to find accurately by exam and ultrasound.
A new method has been developed that involves injecting a small amount of iron dissolved in liquid into the breast that gets absorbed by the lymph nodes making them bright on ultrasound and possible to biopsy. This method has been shown to have results as accurate as standard sentinel lymph node biopsy by comparing them in the operating room. This study will now investigate performing these ultrasounds and biopsies in the office as well as compare these results to the results of the standard sentinel lymph node biopsy in the operating room. The results of this study could help future breast cancer patients to avoid invasive sampling and all of the accompanying risk as well as give patients and the care team an idea of the extent of disease sooner in order to guide management.
- Being tested
- Iron-tracer guided axillary ultrasound and biopsy, Iron tracer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron-tracer guided axillary ultrasound and biopsyProcedure or surgery
After ultrasound identifying sentinel lymph nodes, no more than two nodes will be core-needle biopsied and sent to pathology department for analysis of cancer involvement. The biopsied node(s) will be marked for later identification for the surgeons during the regularly scheduled intraoperative sentinel lymph node biopsy (standard of care).
Iron tracerDrug
Also called Venofer, 75010550
All participants will receive a 30mg injection of subcutaneous iron sucrose into the breast followed by an axillary ultrasound looking for lymph nodes with enhanced reflexivity.
| Study group | Role | What they receive |
|---|---|---|
| Iron-tracer Injection and Biopsy | Experimental | Single injection of 30mg of iron sucrose followed by axillary ultrasound-guided biopsy of lymph node within 2 hours. Receives: Procedure: Iron-tracer guided axillary ultrasound and biopsy; Drug: Iron tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of core needle biopsy of sentinel lymph node
The participants will undergo an outpatient iron tracer-guided ultrasound and axillary lymph node core needle biopsy at "day zero" (purposely done no more than 7 days prior to scheduled breast surgery). The investigators would like to see if this biopsied node was in fact the sentinel lymph node. This will be determined by all of the patients also undergoing their previously scheduled intraoperative sentinel lymph node biopsy (standard of care) at about day 7. The success rate will measure what percentage of the preoperative lymph nodes biopsied with this novel technique were truly sentinel lymph node(s).
Measured: At time of surgery, about 7 days after initial core needle biopsy
Secondary outcomes (1)
Concordance rate of core needle biopsy pathology to sentinel lymph node biopsy pathology
The investigators will measure the concordance rate of the novel iron-tracer guided lymph node core needle biopsy pathology results (determining if cancer cells are present or not) compared to the operative sentinel lymph node pathology results. The novel technique core needle biopsy will occur on day zero. The surgery with concurrent sentinel lymph node biopsy will be on or before day 7, and both pathology reports should be back by day 17.
Measured: At time of pathology reports, about 17 days after initial core needle biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015 (estimated)
- Primary completionJun 2017 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: Unable to enroll subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bret Taback, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610920
- Sponsor's protocol ID
- AAAP8967
- Status last verified
- Mar 2019
- First submitted
- 15 Nov 2015
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kusminsky RE, Witsberger T, Todd Kuenstner J, Willis Trammell S, Schlarb CA, Maxwell D, Richmond BK, Boland JP. Identification of the sentinel node by ultrasonography in patients with breast cancer. Ann Surg Oncol. 2014 Jun;21(6):1969-74. doi: 10.1245/s10434-014-3570-4. Epub 2014 Feb 25.
PubMed 24566860Bailie GR. Comparison of rates of reported adverse events associated with i.v. iron products in the United States. Am J Health Syst Pharm. 2012 Feb 15;69(4):310-20. doi: 10.2146/ajhp110262.
PubMed 22302256
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Sentinel Lymph Nodes by Ultrasound Utilizing Iron Tracer Injection and Preoperative Biopsy in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT02610920
- Acronym / sponsor ID
- AAAP8967
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Dec 2015 (estimated)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 20 Nov 2015 (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.
This study evaluates a new method of testing the lymph nodes in the armpit of patients with breast cancer for tumor involvement. All participants involved in this study will undergo an injection of a small amount of iron dissolved in liquid followed by an ultrasound of the axilla that will make previously invisible lymph nodes visible, allowing them to be sampled in an outpatient setting.
Detailed description
Lymph nodes are small collections of tissue all over the body that drain bodily fluid. These axillary lymph nodes are important in evaluating breast cancer since, if they are positive, it suggests that the cancer cells have spread outside of the breast. The current standard of care is for most breast cancer patients undergoing surgery to have a sentinel lymph node biopsy which is a procedure to take a sample of the lymph nodes in the armpit (also called the axilla) during their breast surgery. However this intraoperative biopsy comes with certain risks such as arm swelling or lymphedema, arm pain, arm numbness/tingling, and/or psychological distress from waiting for the results or the possibility of further interventions. In order to avoid this and have a result before surgery, this study will explore a nonsurgical method of sampling these lymph nodes. Normally suspicious lymph nodes are hard to find accurately by exam and ultrasound.
A new method has been developed that involves injecting a small amount of iron dissolved in liquid into the breast that gets absorbed by the lymph nodes making them bright on ultrasound and possible to biopsy. This method has been shown to have results as accurate as standard sentinel lymph node biopsy by comparing them in the operating room. This study will now investigate performing these ultrasounds and biopsies in the office as well as compare these results to the results of the standard sentinel lymph node biopsy in the operating room. The results of this study could help future breast cancer patients to avoid invasive sampling and all of the accompanying risk as well as give patients and the care team an idea of the extent of disease sooner in order to guide management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron-tracer Injection and Biopsy | Experimental | Procedure: Iron-tracer guided axillary ultrasound and biopsy, Drug: Iron tracerSingle injection of 30mg of iron sucrose followed by axillary ultrasound-guided biopsy of lymph node within 2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients at least 21 years old
- Patients with invasive ductal carcinoma staged T1 or T2 with estrogen receptor and progesterone receptor positive (ER+/PR+) who are scheduled for sentinel lymph node biopsy
- Patients with Ductal Carcinoma In Situ (DCIS) (high or low grade) who are scheduled for sentinel lymph node biopsy including:
- Patients having a mastectomy
- Patients with palpable DCIS
Key exclusion criteria (5 listed)
- Preoperative palpable axillary lymphadenopathy
- Preoperative ultrasound demonstrating suspicious adenopathy
- Previous axillary dissection or previous lymph node biopsy
- Patients with Invasive Lobular Carcinoma
- Patients who are pregnant
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 |
|---|---|---|
| Iron-tracer guided axillary ultrasound and biopsyAfter ultrasound identifying sentinel lymph nodes, no more than two nodes will be core-needle biopsied and sent to pathology department for analysis of cancer involvement. The biopsied node(s) will be marked for later identification for the surgeons during the regularly scheduled intraoperative sentinel lymph node biopsy (standard of care). | Procedure or surgery | Iron-tracer Injection and Biopsy |
| Iron tracerAlso: Venofer, 75010550All participants will receive a 30mg injection of subcutaneous iron sucrose into the breast followed by an axillary ultrasound looking for lymph nodes with enhanced reflexivity. | Drug | Iron-tracer Injection and Biopsy |
Primary outcome
Success rate of core needle biopsy of sentinel lymph node
Time frame: At time of surgery, about 7 days after initial core needle biopsy
The participants will undergo an outpatient iron tracer-guided ultrasound and axillary lymph node core needle biopsy at "day zero" (purposely done no more than 7 days prior to scheduled breast surgery). The investigators would like to see if this biopsied node was in fact the sentinel lymph node. This will be determined by all of the patients also undergoing their previously scheduled intraoperative sentinel lymph node biopsy (standard of care) at about day 7. The success rate will measure what percentage of the preoperative lymph nodes biopsied with this novel technique were truly sentinel lymph node(s).
1 secondary outcome
Concordance rate of core needle biopsy pathology to sentinel lymph node biopsy pathology
Time frame: At time of pathology reports, about 17 days after initial core needle biopsy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Background: PubMed 24566860Kusminsky RE, Witsberger T, Todd Kuenstner J, Willis Trammell S, Schlarb CA, Maxwell D, Richmond BK, Boland JP. Identification of the sentinel node by ultrasonography in patients with breast cancer. Ann Surg Oncol. 2014 Jun;21(6):1969-74. doi: 10.1245/s10434-014-3570-4. Epub 2014 Feb 25.
- Background: PubMed 22302256Bailie GR. Comparison of rates of reported adverse events associated with i.v. iron products in the United States. Am J Health Syst Pharm. 2012 Feb 15;69(4):310-20. doi: 10.2146/ajhp110262.
- Individual participant dataSharing planned: No
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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.
Bret Taback, MD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Iron-tracer guided axillary ultrasound and biopsy and Iron tracer in people with Breast Neoplasm and Carcinoma, Ductal, Breast, run by Columbia University.
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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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 of core needle biopsy of sentinel lymph node (time frame: At time of surgery, about 7 days after initial core needle biopsy). 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 NCT02610920, which also lists 2 linked publications.
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 26 Mar 2019.