Breast Cancer Female, Breast Neoplasms
Conditions
Brief summary
Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-excision.
Interventions
DIAGNOSTIC_TESTPET CT
measurement of surgical margins during lumpectomy
Sponsors
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed