CClinicalTrials.gg
Not yet recruitingNCT07705100UBCTUpdated Jul 27, 2026

Clinical Feasibility Study of Upright, Low-dose, High-resolution, 3D Breast CT (UBCT).

An interventional study of Low dose, upright, dedicated breast CT in Breast Cancer Detection, sponsored by University of Arizona. Not yet recruiting. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by University of Arizona · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
40 Years and older
Sex
Female
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Study 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.

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.

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Conditions studied

  • Breast Cancer Detection
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In context

Lead sponsor

University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Screening cohort

    Women who undergo breast cancer screening using mammography and/or digital breast tomosynthesis.

    Device: Low dose, upright, dedicated breast CT

  • Experimental
    Diagnostic cohort

    Women who have suspicious finding(s) that require biopsy.

    Device: Low dose, upright, dedicated breast CT

Interventions

  • DeviceLow dose, upright, dedicated breast CT

    This study investigates the feasibility of an upright, dedicated breast CT (UBCT) for breast cancer detection.

    Also known as: UBCT

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What researchers measure

Primary outcomes

  1. Feasibility of UBCT

    The proportion of participants who successfully complete the imaging exam using upright, dedicated breast CT (UBCT).

    Time frame: From enrollment to end of study in approximately 6 months.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided — IPD information may be shared with individual academic investigators in accordance with the University of Arizona's data sharing agreement.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07705100
Lead sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 15, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 27, 2026

Study contacts

Michele N Galvan, R.T.
Contact
mngalvan@arizona.edu
520-626-2279
Srinivasan Vedantham, PhD
principal investigator · University of Arizona

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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