Breast CancerNCT00627614
Vibro-Acoustography Imaging in Diagnosing Breast Masses in Women With a Breast Mass or Breast Cancer
A study testing breast imaging study in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of diagnosing breast cancer. PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in diagnosing breast masses in women with a breast mass or breast cancer. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- breast imaging study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Apr 2014
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Suspiciuos breast lesions identified as BI-RADS 4 or 5 and 3
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Not pregnant
- No condition that does not allow proper use of study imaging devices
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
Official title: Identification and Differentiation of Breast Masses by Vibro-Acoustography
RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of diagnosing breast cancer.
PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in diagnosing breast masses in women with a breast mass or breast cancer.
Read the detailed description
OBJECTIVES:
- To study in vivo detection of breast masses by vibro-acoustography (VA) imaging.
- To evaluate the performance of VA imaging in differentiating between benign and malignant breast masses identified as BI-RADS 4 or 5.
OUTLINE: Patients undergo clinical mammography of the breast, followed by vibro-acoustography (VA) imaging using ultrasonography over 90 minutes. Patients may also undergo further imaging using clinical ultrasonography.
- Conditions
- Breast Cancer
- Being tested
- breast imaging study
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast imaging studyOther
- A set of vibro-acoustography (VA) scans will be taken of the breast by an experimental vibro-acoustography device that uses ultrasound for imaging.
2- An ultrasound scan (sonography) of the breast using a clinical ultrasound machine may be taken during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| breast imaging study | Experimental | Not described Receives: Other: breast imaging study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection and differentiation of breast masses with an estimated specificity of ≥ 70% using vibro-acoustography (VA) imaging
Measured: 25 minutes for Breast VA imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startMar 2006
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Azra Alizad, Mayo Clinic
- Investigators
- Azra Alizad, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627614
- Sponsor's protocol ID
- 284-06
- Other IDs
- P30CA015083, CDR0000583016
- Status last verified
- Jun 2015
- First submitted
- 29 Feb 2008
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alizad A, Whaley DH, Urban MW, Carter RE, Kinnick RR, Greenleaf JF, Fatemi M. Breast vibro-acoustography: initial results show promise. Breast Cancer Res. 2012 Sep 29;14(5):R128. doi: 10.1186/bcr3323.
PubMed 23021305Urban MW, Chalek C, Haider B, Thomenius KE, Fatemi M, Alizad A. A beamforming study for implementation of vibro-acoustography with a 1.75-D array transducer. IEEE Trans Ultrason Ferroelectr Freq Control. 2013 Mar;60(3):535-51. doi: 10.1109/TUFFC.2013.2595.
PubMed 23475919Kamimura HA, Urban MW, Carneiro AA, Fatemi M, Alizad A. Vibro-acoustography beam formation with reconfigurable arrays. IEEE Trans Ultrason Ferroelectr Freq Control. 2012 Jul;59(7):1421-31. doi: 10.1109/TUFFC.2012.2343.
PubMed 22828838Urban MW, Alizad A, Aquino W, Greenleaf JF, Fatemi M. A Review of Vibro-acoustography and its Applications in Medicine. Curr Med Imaging Rev. 2011 Nov 1;7(4):350-359. doi: 10.2174/157340511798038648.
PubMed 22423235Chen S, Aquino W, Alizad A, Urban MW, Kinnick R, Greenleaf JF, Fatemi M. Thermal safety of vibro-acoustography using a confocal transducer. Ultrasound Med Biol. 2010 Feb;36(2):343-9. doi: 10.1016/j.ultrasmedbio.2009.10.003.
PubMed 20113864Alizad A, Whaley DH, Greenleaf JF, Fatemi M. Image features in medical vibro-acoustography: in vitro and in vivo results. Ultrasonics. 2008 Nov;48(6-7):559-62. doi: 10.1016/j.ultras.2008.04.014. Epub 2008 May 25.
PubMed 18599102
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Differentiation of Breast Masses by Vibro-Acoustography
- ClinicalTrials.gov ID
- NCT00627614
- Acronym / sponsor ID
- 284-06
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2006
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 3 Mar 2008 (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.
RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of diagnosing breast cancer.
PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in diagnosing breast masses in women with a breast mass or breast cancer.
Detailed description
OBJECTIVES:
- To study in vivo detection of breast masses by vibro-acoustography (VA) imaging.
- To evaluate the performance of VA imaging in differentiating between benign and malignant breast masses identified as BI-RADS 4 or 5.
OUTLINE: Patients undergo clinical mammography of the breast, followed by vibro-acoustography (VA) imaging using ultrasonography over 90 minutes. Patients may also undergo further imaging using clinical ultrasonography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast imaging study | Experimental | Other: breast imaging study |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| breast imaging study1. A set of vibro-acoustography (VA) scans will be taken of the breast by an experimental vibro-acoustography device that uses ultrasound for imaging. 2- An ultrasound scan (sonography) of the breast using a clinical ultrasound machine may be taken during the procedure. | Other | breast imaging study |
Primary outcome
Detection and differentiation of breast masses with an estimated specificity of ≥ 70% using vibro-acoustography (VA) imaging
Time frame: 25 minutes for Breast VA imaging
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 3 Jun 2015.
- Results publication: PubMed 23021305Alizad A, Whaley DH, Urban MW, Carter RE, Kinnick RR, Greenleaf JF, Fatemi M. Breast vibro-acoustography: initial results show promise. Breast Cancer Res. 2012 Sep 29;14(5):R128. doi: 10.1186/bcr3323.
- Results publication: PubMed 23475919Urban MW, Chalek C, Haider B, Thomenius KE, Fatemi M, Alizad A. A beamforming study for implementation of vibro-acoustography with a 1.75-D array transducer. IEEE Trans Ultrason Ferroelectr Freq Control. 2013 Mar;60(3):535-51. doi: 10.1109/TUFFC.2013.2595.
- Results publication: PubMed 22828838Kamimura HA, Urban MW, Carneiro AA, Fatemi M, Alizad A. Vibro-acoustography beam formation with reconfigurable arrays. IEEE Trans Ultrason Ferroelectr Freq Control. 2012 Jul;59(7):1421-31. doi: 10.1109/TUFFC.2012.2343.
- Results publication: PubMed 22423235Urban MW, Alizad A, Aquino W, Greenleaf JF, Fatemi M. A Review of Vibro-acoustography and its Applications in Medicine. Curr Med Imaging Rev. 2011 Nov 1;7(4):350-359. doi: 10.2174/157340511798038648.
- Results publication: PubMed 20113864Chen S, Aquino W, Alizad A, Urban MW, Kinnick R, Greenleaf JF, Fatemi M. Thermal safety of vibro-acoustography using a confocal transducer. Ultrasound Med Biol. 2010 Feb;36(2):343-9. doi: 10.1016/j.ultrasmedbio.2009.10.003.
- Results publication: PubMed 18599102Alizad A, Whaley DH, Greenleaf JF, Fatemi M. Image features in medical vibro-acoustography: in vitro and in vivo results. Ultrasonics. 2008 Nov;48(6-7):559-62. doi: 10.1016/j.ultras.2008.04.014. Epub 2008 May 25.
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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.
Azra Alizad, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breast imaging study in people with Breast Cancer, run by Mayo Clinic 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?
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 3 Jun 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?
Detection and differentiation of breast masses with an estimated specificity of ≥ 70% using vibro-acoustography (VA) imaging (time frame: 25 minutes for Breast VA imaging). 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 NCT00627614, which also lists 6 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 3 Jun 2015.