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Imaging quality and potential clinical relevance of breast computed tomography in-vivo: a single-centre, prospective study

Imaging quality and potential clinical relevance of breast computed tomography in-vivo: a single-centre, prospective study - BreastCT

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015475
Enrollment
330
Registered
2019-05-02
Start date
2019-06-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50

Interventions

Group 1: Imaging of the breast using a Breast CT: The new Breast CT with a high resolution is compared to conventional mammography. Patients are included who are willing to undergo both examinations.

Sponsors

Universitätsspital Zürich
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria - Phase 1 und 2: Patients >18 years with provided informed consent: • Patients with BI-RADS 5/6 lesions • Mastectomy or segmentectomy +/- radiotherapy planned Inclusion criteria - Phase 3: Patients >18 years with provided informed consent: • Patients registered for diagnostic or screening mammography.

Exclusion criteria

Exclusion criteria: Pregnancy, breast-feeding, re-staging after neoadjuvant chemotherapy. In phase 1 clip after biopsy

Design outcomes

Primary

MeasureTime frame
330 patients will be included to obtain the sensitivity and specificity of the breast CT compared to conventional mammography. The mammograms and the breast CT Images will be evaluated seperately by two board-certified radiologists and rated according the BI-RADS criteria.

Countries

Switzerland

Contacts

Public ContactNicole Berger

Universitätsspital Zürich

nicole.berger@usz.ch0041442551111

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026