Breast CancerNCT01852032
Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
A study testing Tomosynthesis Breast Scanning and Breast CT Scanning in people with Breast Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to compare the imaging performance of an investigational breast computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis images), built by Hologic, Incorporated, in a… Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tomosynthesis Breast Scanning and Breast CT Scanning
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 4 Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35 years of age or older
- While male patients will not be explicitly excluded, it is expected that all patients in this study will be women
- Diagnostic findings from prior mammography suspicious for, or highly suggestive of, breast malignancy -BIRADS (Breast Imaging Reporting and Data System) categories 4 and 5
- Scheduled for ultrasound or stereotactic core biopsy
- Ability to lie still on a table top for up to 10 minutes, longer than the typical breast CT duration.
- Ability to understand risks, procedures, and benefits involved
Who cannot join
- Recent breast biopsy
- History of breast augmentation implant
- Pregnant or Positive urine pregnancy test (UPT) or currently breast-feeding
- History of moderate or severe adverse reaction to iodinated contrast injection
- Recent serum creatinine ≥ 1.5 mg/dL
- History of Diabetes Mellitus
Show all 12Show fewer
- Currently taking Glucophage or Glucovance (Metformin)
- History of chronic asthma
- History of allergy to iodine
- Multiple food and/or drug allergy
- Renal disease
- History of pulmonary disease, phobia of breath holding, or other condition that could prevent the subject from being able to perform the 16 second breath hold
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
The purpose of this study is to compare the imaging performance of an investigational breast computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis images), built by Hologic, Incorporated, in a group of patients with suspected breast cancer.
Read the detailed description
The primary aim of this study is the comparison of Beta values of several different CT and Tomosynthesis views (Beta of CT Sagittal View, Beta of CT Coronal View, Beta of CT Axial View, Beta of Tomosynthesis Craniocaudal View, Beta of Tomosynthesis Medial Lateral Oblique View). Lower Beta values correspond to better image quality (less noise, increased cancer detection).
- Conditions
- Breast Cancer
- Being tested
- Tomosynthesis Breast Scanning, Breast CT Scanning
- Keywords
- 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.
Tomosynthesis Breast ScanningRadiation
The breast is positioned and compressed the same way it is in a conventional mammogram using a compression paddle device. The subject will be instructed to hold their breath and not move during the 7- second 3-D tomosynthesis acquisition. The affected breast is positioned with MLO compression. The radiation dose levels for each scan are equivalent to mammography
Breast CT ScanningRadiation
CT scanning will be performed before and after I.V. iodine contrast injection. The subject will lie prone on a large table (which is covered by a foam pad), and she will place the breast to be scanned in a small hole in that tabletop. The hole is surrounded by a soft neoprene "hammock," which will allow the subject's entire upper torso to slump into the scan plane of the device. After positioning of the affected breast by a female mammography technologist, the subject will be instructed to hold their breath for 16 seconds and the pre-contrast scan will commence. There will be no breast compression. Other than the sound of the relatively noisy x-ray system in the room, the subject will not feel or sense any aspect of this scan.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer Patients | Experimental | Tomosynthesis Breast Scanning is done and breast CT Scanning is done. Receives: Radiation: Tomosynthesis Breast Scanning; Radiation: Breast CT Scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta of CT Coronal View
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.
beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Measured: Day 1
Beta of CT Sagittal View
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.
beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Measured: Day 1
Beta of CT Axial View
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.
beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Measured: Day 1
Beta of Tomosynthesis Craniocaudal View
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.
beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Measured: Day 1
Beta of Tomosynthesis Medial Lateral Oblique View
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.
beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startNov 2010
- Primary completion4 Mar 2016
- Study completion4 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc.
- Responsible party
- Sponsor
- Investigators
- John M Boone, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852032
- Sponsor's protocol ID
- 221183
- Status last verified
- Mar 2018
- First submitted
- 29 Oct 2012
- Last updated
- 17 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
- ClinicalTrials.gov ID
- NCT01852032
- Acronym / sponsor ID
- 221183
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Hologic, Inc.
- Study start
- Nov 2010
- Primary completion
- 4 Mar 2016 (actual)
- Study completion
- 4 Mar 2016 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Posted 16 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the imaging performance of an investigational breast computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis images), built by Hologic, Incorporated, in a group of patients with suspected breast cancer.
Detailed description
The primary aim of this study is the comparison of Beta values of several different CT and Tomosynthesis views (Beta of CT Sagittal View, Beta of CT Coronal View, Beta of CT Axial View, Beta of Tomosynthesis Craniocaudal View, Beta of Tomosynthesis Medial Lateral Oblique View). Lower Beta values correspond to better image quality (less noise, increased cancer detection).
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 Patients | Experimental | Radiation: Tomosynthesis Breast Scanning, Radiation: Breast CT ScanningTomosynthesis Breast Scanning is done and breast CT Scanning is done. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 35 years of age or older
- While male patients will not be explicitly excluded, it is expected that all patients in this study will be women
- Diagnostic findings from prior mammography suspicious for, or highly suggestive of, breast malignancy -BIRADS (Breast Imaging Reporting and Data System) categories 4 and 5
- Scheduled for ultrasound or stereotactic core biopsy
- Ability to lie still on a table top for up to 10 minutes, longer than the typical breast CT duration.
Key exclusion criteria (12 listed)
- Recent breast biopsy
- History of breast augmentation implant
- Pregnant or Positive urine pregnancy test (UPT) or currently breast-feeding
- History of moderate or severe adverse reaction to iodinated contrast injection
- Recent serum creatinine ≥ 1.5 mg/dL
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 |
|---|---|---|
| Tomosynthesis Breast ScanningThe breast is positioned and compressed the same way it is in a conventional mammogram using a compression paddle device. The subject will be instructed to hold their breath and not move during the 7- second 3-D tomosynthesis acquisition. The affected breast is positioned with MLO compression. The radiation dose levels for each scan are equivalent to mammography | Radiation | Breast cancer Patients |
| Breast CT ScanningCT scanning will be performed before and after I.V. iodine contrast injection. The subject will lie prone on a large table (which is covered by a foam pad), and she will place the breast to be scanned in a small hole in that tabletop. The hole is surrounded by a soft neoprene "hammock," which will allow the subject's entire upper torso to slump into the scan plane of the device. After positioning of the affected breast by a female mammography technologist, the subject will be instructed to hold their breath for 16 seconds and the pre-contrast scan will commence. There will be no breast compression. Other than the sound of the relatively noisy x-ray system in the room, the subject will not feel or sense any aspect of this scan. | Radiation | Breast cancer Patients |
Primary outcome
Beta of CT Coronal View
Time frame: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Beta of CT Sagittal View
Time frame: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Beta of CT Axial View
Time frame: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Beta of Tomosynthesis Craniocaudal View
Time frame: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Beta of Tomosynthesis Medial Lateral Oblique View
Time frame: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John M Boone, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomosynthesis Breast Scanning and Breast CT Scanning in people with Breast Cancer, run by University of California, Davis 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 6 inclusion and 12 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 Apr 2018. 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?
Yes. Results are posted in the registry (first posted 16 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Beta of CT Coronal View (time frame: Day 1). The study lists 5 primary outcomes in all. 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 Apr 2018; AzTrials last refreshed its copy on 30 Oct 2026.