NCT05359874

Improvement of the Operative Outcome in Patients With Primary VEGF + Unifocal Breast Cancer or DCIS Through the Intraoperative Visualization of the Tumor Using Molecular Imaging and Bevacizumab-IRDye-800CW

Improvement of the Operative Outcome in Patients With Primary VEGF Positive Unifocal Breast Cancer or Ductal Carcinoma in Situ (DCIS) Through the Intraoperative Visualization of the Tumor Using Molecular Imaging and Fluorescent Markers Bevacizumab-IRDye-800CW

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is a prospective, open, non-randomized, multicenter, one-armed, blinded (surgeon), diagnostic clinical trial according to AMG and MPG. The fluorescent marker Bevacizumab-IRDye800CW has advantages over conventional methods of tumor imaging in terms of accuracy, patient safety and validity. In order to be able to detect this marker in vivo, special multispectral fluorescence-reflecting cameras (MFRI) were developed, which can be used for the intraoperative display of the tumor and potentially affected lymph nodes and which are now to be evaluated together with the fluorescence marker.

Detailed description

Complete surgical excision of the tumor (R0 resection) is the cornerstone of any curative therapy concept for cancer. In order to be able to achieve the highest possible rate of R0 resections, the tumor, its localization and spread needs to be more precisely represented. This should be possible through an intraoperative representation of the tumor by means of fluorescence imaging at the molecular level. Vascular Endothelial Growth Factor (VEGF, or VEGF-A), which is expressed differently in normal and tumor tissue, is a suitable marker for molecular imaging, especially in gynecological cancer. Bevacizumab is a genetically engineered humanized monoclonal antibody that is directed against VEGF and is already therapeutically approved for the treatment of breast and ovarian cancer and has also shown efficacy in studies on endometrial cancer. Fluorescence-labeled bevacizumab has advantages over conventional methods of tumor imaging in terms of accuracy, patient safety, cost efficiency and validity. A fluorescent marker, Bevacizumab-IRDye800CW, was developed and recently used in clinical trials in the Netherlands. In order to be able to detect this marker in vivo, special multispectral fluorescence-reflecting cameras (MFRI) were developed, which can be used for intraoperative visualization of the tumor and potentially affected lymph nodes. These systems can now be used to evaluate the fluorescent marker in clinical studies.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab-IRDye800CW	In order to be able to detect this marker in vivo, special multispectral fluorescence-reflecting cameras (MFRI) were developed, which can be used for the intraoperative display of the tumor and potentially affected lymph nodes and which are now to be evaluated together with the fluorescence marker.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2022-05-04
• Last updated: 2022-05-04