Breast ImagingNCT01880580
Cone Beam CT for Breast Imaging
An observational study of Breast Imaging and Breast Cancer, run by Koning Corporation at 1 site in United States.
Trial summary
The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary data for a future extensive clinical trials. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Imaging, Breast Cancer
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2012
- 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: In Group I, up to 100 women, at least 40 years of age, who have had a routine standard mammogram read as BI-RADS® 0, 1, 2, or 3 will also undergo 3D breast imaging using a cone beam CT scanner specifically designed to image the breast. Group II includes forty (40) women, who have had abnormalities detected by physical exam or an imaging modality and are also scheduled for breast biopsy of the index lesion, will also undergo a CBCT of the breast(s), prior to biopsy.
Who may be able to join
- Are at least 40 years of age of any ethnicity
- Had a routine mammogram, read as BI-RADS® 0, 1, 2 or 3
- Will undergo study imaging no later than six months from date of routine mammogram.
- Is able to undergo informed consent.
- Women who are at least 40 years of age of any ethnicity
- Have a palpable abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE) or have a non-palpable abnormality detected by an imaging modality
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- After diagnostic work-up are categorized as BI-RADS® 4 or 5.
- Are scheduled for biopsy either by large gauge needle biopsy or excisional biopsy.
- Will undergo study imaging prior to biopsy and within four weeks of diagnostic work-up.
Who cannot join
- Pregnancy
- Lactation
- Patients with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
- Patients who are unable to tolerate study constraints.
- Patients who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)
- Treatment for enlarged thymus gland as an infant
Show all 27Show fewer
- Irradiation for benign breast conditions, including breast inflammation after giving birth
- Treatment for Hodgkin's disease
- Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
- Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
- Tuberculosis
- Severe scoliosis
- Diagnostic Group:
- Pregnancy
- Lactation
- Patients who have already undergone biopsy for the index lesion
- Patients who are unable or unwilling to undergo biopsy for the lesion of concern
- Patients with physical limitations that may prohibit the patient from resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
- Patients who are unable to tolerate study constraints.
- Patients who have received radiation treatments to the thorax or breast area for malignant and nonmalignant conditions, such as (but not limited to)
- Treatment for enlarged thymus gland as an infant
- Irradiation for benign breast conditions, including breast inflammation after giving birth
- Treatment for Hodgkin's disease
- Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
- Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
- Tuberculosis
- Severe scoliosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Highland Breast Imaging Center
Rochester, New York, 14620
About this study
Official title: Cone Beam CT for Breast Imaging: A Pilot Study
The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary data for a future extensive clinical trials.
- Conditions
- Breast Imaging, 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.
| Study group | Role | What they receive |
|---|---|---|
| Normal Group | In Group I, up to 100 women, at least 40 years of age, who have had a routine standard mammogram read as BI-RADS® 0, 1, 2, or 3 will also undergo 3D breast imaging using a cone beam CT scanner specifically designed to image the breast. Of these 100, we hope to enroll at least 30 subjects with mammograms read as BI-RADS® 0 and at least 30 read as BI-RADS® 3. The BI-RADS® 0 category refers to patients for whom additional imaging is required after a screening mammogram provided incomplete diagnostic information. | |
| Diagnostic Group | The goals of Group II will be to compare the CBCT study with standard imaging for the diagnosis of breast disease in palpable or non-palpable breast lesions (having a BI-RADS® score of 4 or 5). Forty (40) women, who have had abnormalities detected by physical exam or an imaging modality and are also scheduled for breast biopsy of the index lesion, will also undergo a CBCT of the breast(s), prior to biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality of Cone Beam Breast CT
This study was to evaluate the radiation dose, breast coverage, and image quality of cone-beam breast CT compared with a conventional mammographic examination.
Measured: 6 years
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 startJul 2006
- Primary completionJun 2012
- Study completionJun 2012
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 ImagingStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koning Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880580
- Sponsor's protocol ID
- URMC-001
- Status last verified
- Jun 2013
- First submitted
- 15 Jun 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
O'Connell A, Conover DL, Zhang Y, Seifert P, Logan-Young W, Lin CF, Sahler L, Ning R. Cone-beam CT for breast imaging: Radiation dose, breast coverage, and image quality. AJR Am J Roentgenol. 2010 Aug;195(2):496-509. doi: 10.2214/AJR.08.1017.
PubMed 20651210O'Connell AM, Kawakyu-O'Connor D. Dedicated Cone-beam Breast Computed Tomography and Diagnostic Mammography: Comparison of Radiation Dose, Patient Comfort, And Qualitative Review of Imaging Findings in BI-RADS 4 and 5 Lesions. J Clin Imaging Sci. 2012;2:7. doi: 10.4103/2156-7514.93274. Epub 2012 Feb 25.
PubMed 22439131
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cone Beam CT for Breast Imaging: A Pilot Study
- ClinicalTrials.gov ID
- NCT01880580
- Acronym / sponsor ID
- URMC-001
- Conditions
- Breast Imaging, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Koning CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- Jul 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (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 objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary data for a future extensive clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Group | – | –In Group I, up to 100 women, at least 40 years of age, who have had a routine standard mammogram read as BI-RADS® 0, 1, 2, or 3 will also undergo 3D breast imaging using a cone beam CT scanner specifically designed to image the breast. Of these 100, we hope to enroll at least 30 subjects with mammograms read as BI-RADS® 0 and at least 30 read as BI-RADS® 3. The BI-RADS® 0 category refers to patients for whom additional imaging is required after a screening mammogram provided incomplete diagnostic information. |
| Diagnostic Group | – | –The goals of Group II will be to compare the CBCT study with standard imaging for the diagnosis of breast disease in palpable or non-palpable breast lesions (having a BI-RADS® score of 4 or 5). Forty (40) women, who have had abnormalities detected by physical exam or an imaging modality and are also scheduled for breast biopsy of the index lesion, will also undergo a CBCT of the breast(s), prior to biopsy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In Group I, up to 100 women, at least 40 years of age, who have had a routine standard mammogram read as BI-RADS® 0, 1, 2, or 3 will also undergo 3D breast imaging using a cone beam CT scanner specifically designed to image the breast. Group II includes forty (40) women, who have had abnormalities detected by physical exam or an imaging modality and are also scheduled for breast biopsy of the index lesion, will also undergo a CBCT of the breast(s), prior to biopsy.
Key inclusion criteria (9 listed)
- Are at least 40 years of age of any ethnicity
- Had a routine mammogram, read as BI-RADS® 0, 1, 2 or 3
- Will undergo study imaging no later than six months from date of routine mammogram.
- Is able to undergo informed consent.
- Women who are at least 40 years of age of any ethnicity
Key exclusion criteria (27 listed)
- Pregnancy
- Lactation
- Patients with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
- Patients who are unable to tolerate study constraints.
- Patients who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Image Quality of Cone Beam Breast CT
Time frame: 6 years
This study was to evaluate the radiation dose, breast coverage, and image quality of cone-beam breast CT compared with a conventional mammographic examination.
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 19 Jun 2013.
- Results publication: PubMed 20651210O'Connell A, Conover DL, Zhang Y, Seifert P, Logan-Young W, Lin CF, Sahler L, Ning R. Cone-beam CT for breast imaging: Radiation dose, breast coverage, and image quality. AJR Am J Roentgenol. 2010 Aug;195(2):496-509. doi: 10.2214/AJR.08.1017.
- Results publication: PubMed 22439131O'Connell AM, Kawakyu-O'Connor D. Dedicated Cone-beam Breast Computed Tomography and Diagnostic Mammography: Comparison of Radiation Dose, Patient Comfort, And Qualitative Review of Imaging Findings in BI-RADS 4 and 5 Lesions. J Clin Imaging Sci. 2012;2:7. doi: 10.4103/2156-7514.93274. Epub 2012 Feb 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.
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?
An observational study of Breast Imaging and Breast Cancer, run by Koning Corporation 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 9 inclusion and 27 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 19 Jun 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?
Image Quality of Cone Beam Breast CT (time frame: 6 years). 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 NCT01880580, 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 19 Jun 2013.