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Value of Photon Counting Computer Tomography for Breast Diagnosis

Value of Photon Counting Computer Tomography for Breast Diagnosis - PUMA

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028997
Enrollment
110
Registered
2022-08-08
Start date
2022-07-12
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

C50.9

Interventions

Group 1: Patients with confirmed breast carcinoma and current mammography/tomosynthesis or clinical indication for mammography/tomosynthesis and clinical indication for CT thorax with contrast. In add

Sponsors

Department of Radiology, Medical Center - University of Freiburg
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: - Group A: Patients with confirmed breast carcinoma and current mammography/tomosynthesis or clinical indication for mammography/tomosynthesis and clinical indication for CT thorax with contrast medium - Group B: Patients without breast carcinoma with current mammography/tomosynthesis or clinical indication for mammography/tomosynthesis and clinical indication for CT thorax with contrast medium due to other diseases.

Exclusion criteria

Exclusion criteria: Lack of recent mammography (not available, no current clinical indication or not feasible) - Contraindication to contrast medium used - Prone position not possible for health reasons (necessary for CT and, in the case of group A, for MRI examination) - Pregnancy or lactation

Design outcomes

Primary

MeasureTime frame
Evaluation of the presence of breast cancer on PCCT for each breast by breast radiologists blinded to patient data (sensitivity, specificity of PCCT).

Secondary

MeasureTime frame
- Size of breast cancer in PCCT (maximal diameter and volumetry) and - Spread of breast cancer in PCCT (single, multicentric or multifocal) evaluated for each breast by breast radiologists blinded for patient data - Positive margin resection rate

Countries

Germany

Contacts

Public ContactJakob Neubauer

Department of Radiology, Medical Center - University of Freiburg

jakob.neubauer@uniklinik-freiburg.de004976138262

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 8, 2026