Clinical trial · Interventional
VEGF-targeted Fluorescent Tracer Imaging in Breast Cancer
Validation of Uptake of a VEGF-targeted Optical Fluorescent Imaging Tracer in Surgical Specimens of Breast Cancer and Application of Pre- and Intra-operative Human Molecular Fluorescence Imaging Techniques. A Multicenter Feasibility Study
- 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)
The purpose of this study is to determine the uptake, (semi-)quantification and localization of the VEGF targeting fluorescent tracer bevacizumab-IDRye800CW in breast cancer tissue, surrounding healthy tissue, tumor margins and lymph nodes. This is measured in surgical specimens after a single intravenous administration of 4,5 bevacizumab-IDRye800CW, using fluorescence microscopy and macroscopy techniques. Also the safety of bevacizumab-IDRye800CW is assessed. Another purpose is to assess the abilities of three different fluorescent signal detection systems to detect the fluorescent signal pre- and intra-operatively.
Conditions
Conditions (1)
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab-IRDye800CW | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- bevacizumab-IRDye800CW
- description
- In this two stage, non-randomized, non-blinded, prospective, multicenter feasibility study, bevacizumab-IRDye800CW will be administered to a total of 20 patients with proven breast cancer.
- interventionNames
- Drug: bevacizumab-IRDye800CW
Primary outcomes (2)
- measure
- The uptake of bevacizumab-IRDye800CW in breast cancer tissue, surrounding tissue and lymph nodes in surgical specimens by fluorescence microscopy and macroscopy
- timeFrame
- After the last patient is included, which is expected to be within one year after the first inclusion
- description
- Outcome measures: * The accumulation, tissue distribution, lokalization and (semi) quantification of bevacizumab-IRDye800CW in breast cancer tissue, surrounding tissue and lymph nodes. Measured by macroscopy using MSOT, Odessey and MFRI and by microscopy using fluorescence microscope and Odessey. * Correlation of the above to VEGF-levels and other biological parameters.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Patients with proven breast cancer (cytology, histology) who are scheduled to receive operation intervention. * Tumor size of at least 15 mm diameter according to anatomical imaging data. * Signed written informed consent. * Able to comply with the protocol. * WHO performance score 0-2. Exclusion Criteria: * Other invasive malignancy. * Serious other medical conditions. * Pregnant or lactating women. (Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause). * Prior radiotherapy on the involved area. * Major surgery within 28 days before the initiation of the study. * Prior allergic reaction to immunoglobulins or immunoglobulin allergy. * Prior neo-adjuvant chemotherapy. * Breast prosthesis in target breast. UMC Utrecht (FDOT) specific exclusion criteria * Breast is too big to fit in the biggest cup or is too small to fit in the smallest cup of the FDOT system. * Non-intact skin at time of the FDOT procedures. * Breast located skin diseases. * Piercings or tattoos located on the breast/nipple. * Contra-indication for MR procedures or claustrophobia. * Inability to lay prone positioned for the duration of the FDOT procedure (10 minutes) and MR procedure (30 minutes). * Tumor located close to the chest wall as assessed by breast imaging data.
References
Publications (0)
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