Breast CancerPhase 1CBCTBINCT00972413
Cone Beam Computed Tomography for Breast Imaging
A Phase 1 study testing Computed Tomography in people with Breast Cancer, run by Koning Corporation at 1 site in United States.
Trial summary
The primary aim of this study is to investigate the use of cone beam computed tomography (CBCT) for breast imaging in the diagnostic setting by providing a compelling body of evidence incorporating both non-contrast and contrast enhanced CBCT in the study protocol. 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 Cancer
- What is being tested?
- Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to May 2012
- Phase
- 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group I:
- Are at least 40 years of age of any ethnicity
- Had a mammogram, read as BI-RADS® 1 or 2
- Will undergo study imaging no later than four weeks from date of mammogram.
- Is able to undergo informed consent.
- Group II:
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- Are at least 40 years of age of any ethnicity
- Had a routine mammogram, read as BI-RADS® 4 or 5
- Are scheduled for breast biopsy
- Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.
- Is able to undergo informed consent.
- Group III:
- Are at least 40 years of age of any ethnicity
- Had a routine mammogram, read as BI-RADS® 4 or 5
- Are scheduled for breast biopsy
- Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.
- Is able to undergo informed consent.
Who cannot join
- Group I and Group II:
- Pregnancy
- Lactation
- Subjects 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.
- Subjects who are unable to tolerate study constraints.
- Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)
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- Treatment for enlarged thymus gland as an infant
- Irradiation for benign breast conditions, including breast inflammation after giving birth
- Treatment for Hodgkins disease
- Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
- Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
- Tuberculosis
- Severe scoliosis
- Group III:
- Pregnancy
- Lactation
- Subjects 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.
- Subjects who are unable to tolerate study constraints.
- Subjects 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
- Irradiation for benign breast conditions, including breast inflammation after giving birth
- Treatment for Hodgkins disease
- Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
- Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
- Tuberculosis
- Severe scoliosis
- Allergy or previous reaction to iodinated contrast material
- History of renal dysfunction/kidney disease
- Long standing diabetes mellitus
- Multiple myeloma
- Dehydration
- History of nephrotoxic medication use
- Hyperthyroidism
- Diabetic patients on Metformin
- Pheochromocytoma
- Sickle Cell Disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Elizabeth Wende Breast Care
Rochester, New York, 14620
About this study
Official title: Cone Beam Computed Tomography for Breast Imaging and IV Contrast Enhanced Cone Beam Computed Tomography Breast Imaging
The primary aim of this study is to investigate the use of cone beam computed tomography (CBCT) for breast imaging in the diagnostic setting by providing a compelling body of evidence incorporating both non-contrast and contrast enhanced CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions.
- Conditions
- Breast Cancer
- Being tested
- Computed Tomography
- Keywords
- breast cancer, cone beam computed tomography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyRadiation
In Group I, twelve CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.
Computed TomographyRadiation
In Group II , at least fifty (50) study participants, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a breast CBCT specifically designed to image the breast.
Computed TomographyRadiation
In Group III, at least 30 study subjects, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a unilateral intravenous (IV) CE CBCT of the involved breast.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Not described Receives: Radiation: Computed Tomography |
| Group II | Experimental | Not described Receives: Radiation: Computed Tomography |
| Group III | Experimental | Not described Receives: Radiation: Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study's intent is to provide compelling data to illustrate the potential contribution of CBCT for breast imaging, not to generate statistically significant data.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionMay 2012
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.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koning Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Posy Seifert, D.O., Principal investigator, Elizabeth Wende Breast Care, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972413
- Sponsor's protocol ID
- KBCT-001
- Acronym
- CBCTBI
- Status last verified
- Dec 2012
- First submitted
- 3 Sep 2009
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cone Beam Computed Tomography for Breast Imaging and IV Contrast Enhanced Cone Beam Computed Tomography Breast Imaging
- ClinicalTrials.gov ID
- NCT00972413
- Acronym / sponsor ID
- CBCTBI / KBCT-001
- Conditions
- Breast Cancer
- Keywords
- breast cancer, cone beam computed tomography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Koning CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Sep 2009 (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 primary aim of this study is to investigate the use of cone beam computed tomography (CBCT) for breast imaging in the diagnostic setting by providing a compelling body of evidence incorporating both non-contrast and contrast enhanced CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Radiation: Computed Tomography |
| Group II | Experimental | Radiation: Computed Tomography |
| Group III | Experimental | Radiation: Computed Tomography |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Are at least 40 years of age of any ethnicity
- Had a mammogram, read as BI-RADS® 1 or 2
- Will undergo study imaging no later than four weeks from date of mammogram.
- Is able to undergo informed consent.
- Are at least 40 years of age of any ethnicity
Key exclusion criteria (36 listed)
- Pregnancy
- Lactation
- Subjects 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.
- Subjects who are unable to tolerate study constraints.
- Subjects 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyIn Group I, twelve CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam. | Radiation | Group I |
| Computed TomographyIn Group II , at least fifty (50) study participants, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a breast CBCT specifically designed to image the breast. | Radiation | Group II |
| Computed TomographyIn Group III, at least 30 study subjects, who are categorized as BI-RADS® 4, 5 based on prior diagnostic work-up and are also scheduled for breast biopsy of a lesion, will undergo a unilateral intravenous (IV) CE CBCT of the involved breast. | Radiation | Group III |
Primary outcome
The study's intent is to provide compelling data to illustrate the potential contribution of CBCT for breast imaging, not to generate statistically significant data.
Time frame: 3 years
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 17 Dec 2012.
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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.
Posy Seifert, D.O. principal investigator
Elizabeth Wende Breast Care, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computed Tomography in people with 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 17 inclusion and 36 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 17 Dec 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
The study's intent is to provide compelling data to illustrate the potential contribution of CBCT for breast imaging, not to generate statistically significant data. (time frame: 3 years). 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 17 Dec 2012.