Focus: Breast Cancer With Axillary Node MetastasisNCT01920139
Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy
A study testing Fine needle aspiration and core biopsy of lymph node, Axillary surgery and Titanium marker in people with Focus: Breast Cancer With Axillary Node Metastasis, run by University of Pittsburgh at 1 site in United States.
Trial summary
The study was performed to determine if either ultrasound guided core biopsy or fine needle aspiration of an axillary lymph node has superior sensitivity in detecting metastatic carcinoma from the ipsilateral breast. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Focus: Breast Cancer With Axillary Node Metastasis
- What is being tested?
- Fine needle aspiration and core biopsy of lymph node, Axillary surgery and Titanium marker
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with breast cancer and abnormal ipsilateral axillary nodes visible on sonography.
Who cannot join
- Inability to understand consent form.
- Emotionally unprepared to discuss possibility of axillary metastasis
- Node not amenable to core biopsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients Suspected of Having Breast Cancer.
The study was performed to determine if either ultrasound guided core biopsy or fine needle aspiration of an axillary lymph node has superior sensitivity in detecting metastatic carcinoma from the ipsilateral breast.
Read the detailed description
Women with suspected or recently diagnosed breast cancer and ipsilateral abnormal appearing axillary lymph nodes underwent fine needle aspiration immediately followed by core biopsy of the same lymph node.Cytology results from the fine needle aspiration (FNA)and histology from the core biopsy were compared to surgical pathology from axillary node excision to determine if either method of percutaneous node sampling was more sensitive in detecting metastasis. Pain during each procedure was also compared.
- Being tested
- Fine needle aspiration and core biopsy of lymph node, Axillary surgery, Titanium marker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine needle aspiration and core biopsy of lymph nodeProcedure or surgery
Ultrasound guided fine needle aspiration of an abnormal lymph node followed by ultrasound guided core biopsy of the same node followed by clip placement into the node.
Axillary surgeryProcedure or surgery
Patients underwent axillary node dissection or excision of setinel axillary nodes at the time of surgical treatment of their breast cancer.
Titanium markerOther
A titanium marker was deposited into the lymph node that was percutaneously biopsied , immediately after the last tissue sample obtained.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer and Axillary Adenopathy | Other | Women with breast cancer with abnormal appearing ipsilateral axillary nodes undergoing fine needle aspiration and core biopsy of a lymph node. Receives: Procedure: Fine needle aspiration and core biopsy of lymph node; Procedure: Axillary surgery; Other: Titanium marker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of metastatic nodes found at axillary surgery that were identified pre-surgically by FNA vs. core biopsy
Results of FNA cytology and core biopsy histology are compared to axillary surgery results.
Measured: 1 week to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startDec 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focus: Breast Cancer With Axillary Node MetastasisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Suros Surgical (now Hologic )
- Responsible party
- Principal investigator, Marie Ganott, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920139
- Sponsor's protocol ID
- PRO07100450
- Status last verified
- Aug 2013
- First submitted
- 1 Aug 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ganott MA, Zuley ML, Abrams GS, Lu AH, Kelly AE, Sumkin JH, Chivukula M, Carter G, Austin RM, Bandos AI. Ultrasound Guided Core Biopsy versus Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients with Breast Cancer. ISRN Oncol. 2014 Feb 4;2014:703160. doi: 10.1155/2014/703160. eCollection 2014.
PubMed 24649373
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Core Biopsy vs Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients Suspected of Having Breast Cancer.
- ClinicalTrials.gov ID
- NCT01920139
- Acronym / sponsor ID
- PRO07100450
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Suros Surgical (now Hologic )
- Study start
- Dec 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Aug 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 study was performed to determine if either ultrasound guided core biopsy or fine needle aspiration of an axillary lymph node has superior sensitivity in detecting metastatic carcinoma from the ipsilateral breast.
Detailed description
Women with suspected or recently diagnosed breast cancer and ipsilateral abnormal appearing axillary lymph nodes underwent fine needle aspiration immediately followed by core biopsy of the same lymph node.Cytology results from the fine needle aspiration (FNA)and histology from the core biopsy were compared to surgical pathology from axillary node excision to determine if either method of percutaneous node sampling was more sensitive in detecting metastasis. Pain during each procedure was also compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer and Axillary Adenopathy | Other | Procedure: Fine needle aspiration and core biopsy of lymph node, Procedure: Axillary surgery, Other: Titanium markerWomen with breast cancer with abnormal appearing ipsilateral axillary nodes undergoing fine needle aspiration and core biopsy of a lymph node. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women with breast cancer and abnormal ipsilateral axillary nodes visible on sonography.
Key exclusion criteria (3 listed)
- Inability to understand consent form.
- Emotionally unprepared to discuss possibility of axillary metastasis
- Node not amenable to core biopsy
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 and core biopsy of lymph nodeUltrasound guided fine needle aspiration of an abnormal lymph node followed by ultrasound guided core biopsy of the same node followed by clip placement into the node. | Procedure or surgery | Breast cancer and Axillary Adenopathy |
| Axillary surgeryPatients underwent axillary node dissection or excision of setinel axillary nodes at the time of surgical treatment of their breast cancer. | Procedure or surgery | Breast cancer and Axillary Adenopathy |
| Titanium markerA titanium marker was deposited into the lymph node that was percutaneously biopsied , immediately after the last tissue sample obtained. | Other | Breast cancer and Axillary Adenopathy |
Primary outcome
Fraction of metastatic nodes found at axillary surgery that were identified pre-surgically by FNA vs. core biopsy
Time frame: 1 week to 10 months
Results of FNA cytology and core biopsy histology are compared to axillary surgery results.
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 9 Aug 2013.
- Derived from this study: PubMed 24649373Ganott MA, Zuley ML, Abrams GS, Lu AH, Kelly AE, Sumkin JH, Chivukula M, Carter G, Austin RM, Bandos AI. Ultrasound Guided Core Biopsy versus Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients with Breast Cancer. ISRN Oncol. 2014 Feb 4;2014:703160. doi: 10.1155/2014/703160. eCollection 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and core biopsy of lymph node, Axillary surgery and Titanium marker in people with Focus: Breast Cancer With Axillary Node Metastasis, run by University of Pittsburgh 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 1 inclusion and 3 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 9 Aug 2013. 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?
Fraction of metastatic nodes found at axillary surgery that were identified pre-surgically by FNA vs. core biopsy (time frame: 1 week to 10 months). 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 NCT01920139, 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 9 Aug 2013.