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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Michele N Galvan, R.T.
- Telefonnummer: 520-626-2279
- E-post: mngalvan@arizona.edu
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
|
|
Eksperimentell: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of UBCT
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Srinivasan Vedantham, PhD, University of Arizona
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1904498647
- R01CA241709 (U.S. NIH-stipend/kontrakt)
- IRG 18-161-40 (Annet stipend/finansieringsnummer: American Cancer Society)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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