Status:
RECRUITING
Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.
Lead Sponsor:
University Hospital, Ghent
Conditions:
Breast Cancer Female
Breast Neoplasms
Eligibility:
FEMALE
18-85 years
Phase:
NA
Brief Summary
Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-excision.
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04343079
Start Date
January 1 2018
End Date
December 31 2025
Last Update
January 23 2024
Active Locations (1)
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1
University Hospital Ghent
Ghent, Oost Vlaanderen, Belgium, 9000