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

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 - VEGF-Targeted Fluorescent Tracer Imaging in Breast Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39185

Enrollment

Registered

2011-09-07

Start date

2012-03-12

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

All included patients receive an injection with fluorescently labeled bevacizumab (5mg) once. Blood samples will be taken at 4 time points. The first and second time, 4mL blood will be drawn. The 3

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age >= 18 years. Patients with proven breast cancer (cytology, histology) who are scheduled to receive operation intervention. Tumor size of at least 5 mm (0,5 cm) diameter according to anatomical imaging data. Signed written informed consent. Able to comply with the protocol. WHO performance score 0-2.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Patient related study procedures The study consists of a total of five study procedure related visits. During a screening visit, eligibility will be evaluated and patient characteristics will be collected. During the administration visit (3 days before surgery), pre-operative optical imaging will take place and a blood sample will be taken. Subsequently, 4.5 mg of bevacizumab-IRDye 800CW will be administered intravenously. The patient will then be observed for 4 hours. Thereafter, another optical imaging procedure will take place and a blood sample will be taken. During a visit approximately 36 hours after administration of the tracer, an optical imaging procedure will take place. Directly before surgery, an optical imaging procedure will take place and a blood sample will be taken. During surgery, the MFRI camera will be used to detect a fluorescent signal. At an outpatient visit (approximately 10 days after surgery), the last blood sample will be taken. Study aims - (Semi-)quantification and localization of a fluorescent signal of tumor, tumor margins, surrounding tissue and lymph nodes in surgical specimens. - Collection of safety data of Bevacizumab-IRDye800CW and to assess immunogenicity. - Localization of Bevacizumab-IRDye 800CW in (sub-)cellular compartments. - (Semi-)quantification and localization of a fluorescent signal of tumor, tumor margins, surrounding tissue and lymph nodes prior and during surgery by MFRI. - Exploration of optimal imaging time point, pharmacokinetics and localization of a fluorescent signal of tumor, surrounding tissue and lymph nodes pre-operative. - Correlation of collected data to VEGF levels and other (VEGF related) biological parameters.	—

Measure

Time frame

Patient related study procedures The study consists of a total of five study procedure related visits. During a screening visit, eligibility will be evaluated and patient characteristics will be collected. During the administration visit (3 days before surgery), pre-operative optical imaging will take place and a blood sample will be taken. Subsequently, 4.5 mg of bevacizumab-IRDye 800CW will be administered intravenously. The patient will then be observed for 4 hours. Thereafter, another optical imaging procedure will take place and a blood sample will be taken. During a visit approximately 36 hours after administration of the tracer, an optical imaging procedure will take place. Directly before surgery, an optical imaging procedure will take place and a blood sample will be taken. During surgery, the MFRI camera will be used to detect a fluorescent signal. At an outpatient visit (approximately 10 days after surgery), the last blood sample will be taken. Study aims - (Semi-)quantification and localization of a fluorescent signal of tumor, tumor margins, surrounding tissue and lymph nodes in surgical specimens. - Collection of safety data of Bevacizumab-IRDye800CW and to assess immunogenicity. - Localization of Bevacizumab-IRDye 800CW in (sub-)cellular compartments. - (Semi-)quantification and localization of a fluorescent signal of tumor, tumor margins, surrounding tissue and lymph nodes prior and during surgery by MFRI. - Exploration of optimal imaging time point, pharmacokinetics and localization of a fluorescent signal of tumor, surrounding tissue and lymph nodes pre-operative. - Correlation of collected data to VEGF levels and other (VEGF related) biological parameters.

—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)