Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.

Not Applicable

Recruiting

• Conditions: Breast Cancer Female; Breast Neoplasms

• Registration Number: NCT04343079
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-excision.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-20
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• • female and 18 years of age or older

  • diagnosed with an early-stage (T1 or T2, and N0 or N1; according to the TNM-classification) invasive breast cancer
  • eligible for breast conserving surgery

Exclusion Criteria

• • Pregnancy or lactation

  • Diabetes
  • Multifocal tumor disease
  • Diagnosis of inflammatory breast cancer
  • Appointment at the nuclear medicine department for 18F-FDG administration would result in a unacceptable delay of surgery
  • Subject has had exposure to ionizing radiation of more than 1 mSv in other research studies within the last 12 months
  • Subject has recently (<60 days) or is simultaneously participating in another clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
investigate the ability of (micro)PET/CT to evaluate the excision margins and determine negativity of these margins, as compared to the gold standard of sectional histopathological evaluation.	2 year	study the feasibility of PET/CT

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Oost Vlaanderen, Belgium