Breast Cancer DetectionUBCTNCT07705100
Clinical Feasibility Study of Upright, Low-dose, High-resolution, 3D Breast CT (UBCT).
A study testing Low dose, upright, dedicated breast CT in people with Breast Cancer Detection, run by University of Arizona.
Trial summary
The investigators are doing this study to find out if a new kind of breast imaging (called upright dedicated breast CT or UBCT) can help doctors to see the small structures in breast tissue more clearly in 3-D and without overlap. 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 Detection
- What is being tested?
- Low dose, upright, dedicated breast CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- For the screening cohort, the inclusion criteria are, women:
- (1) who were 40 years of age or older (typical screening age range), and,
- (2) who were asymptomatic, and,
- (3) who underwent or scheduled to undergo a standard-of-care 2-view bilateral digital breast tomosynthesis screening exam.
- For the diagnostic cohort, the inclusion criteria are, women:
- (1) who were 40 years of age or older, and,
- (2) who underwent a standard-of-care 2-view bilateral digital breast tomosynthesis exam, and,
- (3) who were assigned BI-RADS category 4 or 5 after diagnostic work-up and are scheduled for biopsy.
Who cannot join
- Males
- Women less than 40 years old
- pregnant or lactating women
- women with physical limitations (e.g., kyphosis) that may prohibit UBCT exam
- women who have received radiation treatments to the thorax
- women who have participated in a prior breast clinical trial that gave additional radiation dose
- women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as tuberculosis, and severe scoliosis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The investigators are doing this study to find out if a new kind of breast imaging (called upright dedicated breast CT or UBCT) can help doctors to see the small structures in breast tissue more clearly in 3-D and without overlap.
The breast imaging device that will be used in this study (UBCT) is not FDA-approved, so this is a research study. The machine has been designed to remove mammography-like breast compression and use radiation dose comparable to mammography. The breast CT device will take multiple x-ray pictures of the subjects breast in approximately 20 seconds and create a 3-D image of the breast. It does not compress or squish the breast like a mammogram.
- Conditions
- Breast Cancer Detection
- Being tested
- Low dose, upright, dedicated breast CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose, upright, dedicated breast CTDevice
Also called UBCT
This study investigates the feasibility of an upright, dedicated breast CT (UBCT) for breast cancer detection.
| Study group | Role | What they receive |
|---|---|---|
| Screening cohort | Experimental | Women who undergo breast cancer screening using mammography and/or digital breast tomosynthesis. Receives: Device: Low dose, upright, dedicated breast CT |
| Diagnostic cohort | Experimental | Women who have suspicious finding(s) that require biopsy. Receives: Device: Low dose, upright, dedicated breast CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of UBCT
The proportion of participants who successfully complete the imaging exam using upright, dedicated breast CT (UBCT).
Measured: From enrollment to end of study in approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer DetectionStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Srinivasan Vedantham, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705100
- Sponsor's protocol ID
- 1904498647
- Other IDs
- R01CA241709, IRG 18-161-40
- Acronym
- UBCT
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: IPD information may be shared with individual academic investigators in accordance with the University of Arizona's data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility Study of Upright, Low-dose, High-resolution, 3D Breast CT (UBCT).
- ClinicalTrials.gov ID
- NCT07705100
- Acronym / sponsor ID
- UBCT / 1904498647
- Conditions
- Breast Cancer Detection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jul 2026 (actual)
- 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 investigators are doing this study to find out if a new kind of breast imaging (called upright dedicated breast CT or UBCT) can help doctors to see the small structures in breast tissue more clearly in 3-D and without overlap.
The breast imaging device that will be used in this study (UBCT) is not FDA-approved, so this is a research study. The machine has been designed to remove mammography-like breast compression and use radiation dose comparable to mammography. The breast CT device will take multiple x-ray pictures of the subjects breast in approximately 20 seconds and create a 3-D image of the breast. It does not compress or squish the breast like a mammogram.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening cohort | Experimental | Device: Low dose, upright, dedicated breast CTWomen who undergo breast cancer screening using mammography and/or digital breast tomosynthesis. |
| Diagnostic cohort | Experimental | Device: Low dose, upright, dedicated breast CTWomen who have suspicious finding(s) that require biopsy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- (1) who were 40 years of age or older (typical screening age range), and,
- (2) who were asymptomatic, and,
- (3) who underwent or scheduled to undergo a standard-of-care 2-view bilateral digital breast tomosynthesis screening exam.
- (1) who were 40 years of age or older, and,
- (2) who underwent a standard-of-care 2-view bilateral digital breast tomosynthesis exam, and,
Key exclusion criteria (7 listed)
- Males
- Women less than 40 years old
- pregnant or lactating women
- women with physical limitations (e.g., kyphosis) that may prohibit UBCT exam
- women who have received radiation treatments to the thorax
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 |
|---|---|---|
| Low dose, upright, dedicated breast CTAlso: UBCTThis study investigates the feasibility of an upright, dedicated breast CT (UBCT) for breast cancer detection. | Device | Diagnostic cohort, Screening cohort |
Primary outcome
Feasibility of UBCT
Time frame: From enrollment to end of study in approximately 6 months.
The proportion of participants who successfully complete the imaging exam using upright, dedicated breast CT (UBCT).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided. IPD information may be shared with individual academic investigators in accordance with the University of Arizona's data sharing agreement.
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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.
Srinivasan Vedantham, PhD principal investigator
University of Arizona
Questions about this trial
What is this clinical trial studying?
A study testing Low dose, upright, dedicated breast CT in people with Breast Cancer Detection, run by University of Arizona.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele N Galvan, R.T. (520-626-2279, mngalvan@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of UBCT (time frame: From enrollment to end of study in approximately 6 months.). 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 27 Jul 2026.