Comparison of intraoperative specimen radiography (IOSR) with or without KliniTray system in patients with breast conserving surgery of intraductal breast cancer

Comparison of intraoperative specimen radiography (IOSR) with or without KliniTray system in patients with breast conserving surgery of intraductal breast cancer - KliniTray Intraductal Breast Cancer Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011527

Enrollment

110

Registered

2017-01-03

Start date

2017-01-05

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

D05.1

Interventions

Group 1: In patients with intraductal breast cancer undergoing breast conserving surgery the intraoperative specimen radiography (IOSR) is carried out in conventional matter (specimen ist orientated u

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: patient signed informed consent; histologically proven intraductal carcinoma with microcalcifications (inclusive early invasive breast cancer); planned breast-conserving surgery; age >/= 18 years

Exclusion criteria

Exclusion criteria: no microcalcifications; recent surgery for diagnostic purpose planned mastectomy age<18

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the pathological free margin (minimal pathological resection margin >/= 2 mm)	—

Secondary

Measure	Time frame
effiency of immediate re-excision in case of radiological margins <5 mm to reach pathological free margins; agreement of orientation of minimal radiological and pathological margins; evaluation of digital tomosynthesis for specimen radiography; cost-benefit-analysis	—

Countries

Germany

Contacts

Public ContactAngrit Stachs

UFK Rostock

angrit.stachs@uni-rostock.de038144018463

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 12, 2026