Clinical trial · Interventional
Intra-operative PET-CT: a Novel Approach to Determine Excision Margins in Lumpectomy Breast Cancer.
NCT04343079CI-TRIAL-00073179unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Examination of the feasibility of intra-operative pet CT to detect surgical margins in breast conservative surgery to prevent re-excision.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- braeast cancer
- description
- breast cancer patients
- interventionNames
- Diagnostic Test: PET CT
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 2 year
- description
- study the feasibility of PET/CT
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDe Crem AS, Tummers P, Depypere H, Braems G, Salihi R, Vergauwen G, Cisternino G, Van de Vijver K, De Visschere P, De Man K, Van den Broeck B, Hendrickx S, Veldeman L, Monten C, Debacker JM, Denys H, Goker M. Breast cancer Intraoperative Margin Assessment using specimen PET-CT (BIMAP). NPJ Breast Cancer. 2025 Sep 26;11(1):101. doi: 10.1038/s41523-025-00818-8. PMID 41006264