Using PET-CT during surgery to improve breast cancer treatment
Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.
This study is testing if using special imaging during breast surgery can help doctors see cancer more clearly and reduce the chances of needing more surgeries later.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ghent, Oost Vlaanderen) |
| Trial ID | NCT04343079 on ClinicalTrials.gov |
What this trial studies
This study examines the feasibility of using intra-operative PET-CT imaging to accurately determine surgical margins during breast-conserving surgery for early-stage breast cancer. By detecting cancerous tissue more effectively, the goal is to reduce the need for re-excision surgeries. The approach involves administering a radiotracer and utilizing PET-CT technology to visualize the tumor margins in real-time during the surgical procedure. This innovative method aims to enhance surgical outcomes and patient care.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18 and older diagnosed with early-stage invasive breast cancer eligible for breast-conserving surgery.
Not a fit: Patients who are pregnant, have diabetes, or have multifocal tumor disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rates of re-excision surgeries for breast cancer patients.
How similar studies have performed: While the use of imaging techniques in surgical settings is not entirely novel, this specific application of intra-operative PET-CT for breast cancer excision margins is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ghent, Oost Vlaanderen
- University Hospital Ghent — Ghent, Oost Vlaanderen, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.