Breast CancerNCT01681901
Ultrasound in Detecting Lymph Node Metastasis in Older Patients Undergoing Breast Sonography
An observational study of Breast Cancer, run by Ohio State University Comprehensive Cancer Center.
Trial summary
This pilot clinical trial studies ultrasound in detecting lymph node metastasis in older patients with undergoing breast sonography. Diagnostic procedures, such as ultrasound, may help find breast cancer and find out how far the disease has spread Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ultrasound imaging
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 7 Jun 2006to Apr 2007
- Phase
- Observational
- 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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion Criteria: * Patients referred for a breast ultrasound * Patients who have had a mammogram with a Breast Imaging Reporting and Data System (BIRADS) of >= 4 * Patients who are undiagnosed for breast cancer
Who may be able to join
- Patients referred for a breast ultrasound
- Patients who have had a mammogram with a Breast Imaging Reporting and Data System (BIRADS) of >= 4
- Patients who are undiagnosed for breast cancer
Who cannot join
- Patients who have had breast cancer surgery
About this study
Official title: Lymph Node Evaluation in the Axilla of Symptomatic Older Women During Breast Sonography.
This pilot clinical trial studies ultrasound in detecting lymph node metastasis in older patients with undergoing breast sonography. Diagnostic procedures, such as ultrasound, may help find breast cancer and find out how far the disease has spread
Read the detailed description
PRIMARY OBJECTIVES:
- To develop a reliable and consistent set of guidelines for utilizing diagnostic ultrasound to assess axillary lymph nodes for patient suspicious of breast cancer with possible nodal metastasis.
SECONDARY OBJECTIVES:
- To explore whether the data collected can be used for pathologic validation of metastatic disease.
OUTLINE:
Patients undergo breast ultrasound.
- Conditions
- Breast Cancer
- Being tested
- ultrasound imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound imagingProcedure or surgery
Also called ultrasonography, ultrasound, ultrasound test
Undergo ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (ultrasound) | Patients undergo breast ultrasound imaging. Receives: Procedure: ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of successful evaluations, defined as the consistent capture of the data for geometry, morphology, qualitative vascular information, and quantitative vascular information on 3 axillary lymph nodes
The proposed methodology will be considered unfeasible if the proportion of successful evaluations is =< 0.7.
Measured: at 15 minutes following breast sonogram
Secondary outcomes (4)
Accuracy of lymph node geometry, measured with a longitudinal and transverse ratio, to determine guidelines for characterizing micro metastases to the lymph nodes
Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The longitudinal-transverse ratio will be investigated for cutoff points that yield high sensitivity and to see if results are consistent with prior studies suggesting a ratio of 1.5 or less is indicative of abnormality. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed.
Measured: 3 months
Accuracy of lymph node morphology, assessed for shape and echogenicity, to determine guidelines for characterizing micro metastases to the lymph nodes
Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed.
Measured: 3 months
Accuracy of lymph node vascularity, assessed with color doppler, to determine guidelines for characterizing micro metastases to the lymph nodes
Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed.
Measured: 3 months
Accuracy of lymphatic flow, measured with spectral doppler, to determine guidelines for characterizing micro metastases to the lymph nodes
Descriptive statistics, such as means, proportions and standard deviations, will be summarized. The percent agreement between the resulting diagnostic criteria and the surgical/pathological results will be assessed.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study start7 Jun 2006
- Primary completionApr 2007 (estimated)
- Study completionApr 2007 (estimated)
Why it stopped: no patient accrual
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 Ohio State University Comprehensive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Evans, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681901
- Sponsor's protocol ID
- OSU-06010
- Other IDs
- NCI-2012-01176
- Status last verified
- Apr 2017
- First submitted
- 5 Sep 2012
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymph Node Evaluation in the Axilla of Symptomatic Older Women During Breast Sonography.
- ClinicalTrials.gov ID
- NCT01681901
- Acronym / sponsor ID
- OSU-06010
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no patient accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 7 Jun 2006 (actual)
- Primary completion
- Apr 2007 (estimated)
- Study completion
- Apr 2007 (estimated)
- First posted
- 10 Sep 2012 (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 pilot clinical trial studies ultrasound in detecting lymph node metastasis in older patients with undergoing breast sonography. Diagnostic procedures, such as ultrasound, may help find breast cancer and find out how far the disease has spread
Detailed description
PRIMARY OBJECTIVES:
- To develop a reliable and consistent set of guidelines for utilizing diagnostic ultrasound to assess axillary lymph nodes for patient suspicious of breast cancer with possible nodal metastasis.
SECONDARY OBJECTIVES:
- To explore whether the data collected can be used for pathologic validation of metastatic disease.
OUTLINE:
Patients undergo breast ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (ultrasound) | – | Procedure: ultrasound imagingPatients undergo breast ultrasound imaging. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * Patients referred for a breast ultrasound * Patients who have had a mammogram with a Breast Imaging Reporting and Data System (BIRADS) of >= 4 * Patients who are undiagnosed for breast cancer
Key inclusion criteria (3 listed)
- Patients referred for a breast ultrasound
- Patients who have had a mammogram with a Breast Imaging Reporting and Data System (BIRADS) of >= 4
- Patients who are undiagnosed for breast cancer
Key exclusion criteria (1 listed)
- Patients who have had breast cancer surgery
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 |
|---|---|---|
| ultrasound imagingAlso: ultrasonography, ultrasound, ultrasound testUndergo ultrasound | Procedure or surgery | Diagnostic (ultrasound) |
Primary outcome
Proportion of successful evaluations, defined as the consistent capture of the data for geometry, morphology, qualitative vascular information, and quantitative vascular information on 3 axillary lymph nodes
Time frame: at 15 minutes following breast sonogram
The proposed methodology will be considered unfeasible if the proportion of successful evaluations is =< 0.7.
4 secondary outcomes
Accuracy of lymph node geometry, measured with a longitudinal and transverse ratio, to determine guidelines for characterizing micro metastases to the lymph nodes
Time frame: 3 months
Accuracy of lymph node morphology, assessed for shape and echogenicity, to determine guidelines for characterizing micro metastases to the lymph nodes
Time frame: 3 months
Accuracy of lymph node vascularity, assessed with color doppler, to determine guidelines for characterizing micro metastases to the lymph nodes
Time frame: 3 months
Accuracy of lymphatic flow, measured with spectral doppler, to determine guidelines for characterizing micro metastases to the lymph nodes
Time frame: 3 months
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 13 Apr 2017.
- The JamelsineLink 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.
Kevin Evans principal investigator
Ohio State University Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Ohio State University Comprehensive Cancer Center.
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 3 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: withdrawn, as of the sponsor's last update on 13 Apr 2017. 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.
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?
Proportion of successful evaluations, defined as the consistent capture of the data for geometry, morphology, qualitative vascular information, and quantitative vascular information on 3 axillary lymph nodes (time frame: at 15 minutes following breast sonogram). 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 13 Apr 2017.