Clinical Feasibility Study of Upright, Low-dose, High-resolution, 3D Breast CT (UBCT). (UBCT)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Michele N Galvan, R.T.
- Telefonnummer: 520-626-2279
- E-post: mngalvan@arizona.edu
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Screening cohort
Women who undergo breast cancer screening using mammography and/or digital breast tomosynthesis.
|
This study investigates the feasibility of an upright, dedicated breast CT (UBCT) for breast cancer detection.
Andra namn:
|
|
Experimentell: Diagnostic cohort
Women who have suspicious finding(s) that require biopsy.
|
This study investigates the feasibility of an upright, dedicated breast CT (UBCT) for breast cancer detection.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility of UBCT
Tidsram: 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).
|
From enrollment to end of study in approximately 6 months.
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Srinivasan Vedantham, PhD, University of Arizona
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 1904498647
- R01CA241709 (U.S.S. NIH-anslag/kontrakt)
- IRG 18-161-40 (Annat bidrag/finansieringsnummer: American Cancer Society)
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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