Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.
Not Applicable
Recruiting
- Conditions
- Breast Cancer FemaleBreast Neoplasms
- Interventions
- Diagnostic Test: PET CT
- 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
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
- Arm && Interventions
Group Intervention Description braeast cancer PET CT breast cancer patients
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Oost Vlaanderen, Belgium