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

NCT05359874 | Withdrawn Phase 2

• 1 other identifier: DOT-1871-KIE-0120-I
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Determination of the sensitivity and specificity of bevacizumab- IRDye800CW

  Determination of the sensitivity and specificity of bevacizumab- IRDye800CW with regard to the identification of the tumor margins compared with the histopathological findings (resection result R0, R1) as the gold standard

  21 days

Secondary Outcomes (1)

• Safety and Toxicity of Bevacizumab-IRDye800CW will be analyzed by absolute and relative frequencies of Safety events

  21 days

Study Arms (1)

treatment arm

EXPERIMENTAL

Drug: Bevacizumab-IRDye800CW

Interventions

Bevacizumab-IRDye800CW DRUG

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.

Also known as: Device: special multispectral fluorescence-reflecting cameras

treatment arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women of age ≥ 18 years able to give consent who have been informed in detail about the study beforehand and have given written consent to participate
• Patients with histologically confirmed unifocal VEGF-positive invasive breast cancer with an indication for BET
• Patients with histologically confirmed unilateral VEGF-positive DCIS with an indication for BET
• ECOG performance ≤ 2
• Pre-menopausal women had a negative pregnancy test prior to administration of the study medication
• Negative pregnancy test (serum) within 10 days prior to administration of the test medication in all women of childbearing age with results available prior to the start of therapy (or postmenopausal; age ≥60 and no menses over ≥ 1 year without any other medical cause; or hysterectomy, or tube ligation, or bilaterally guided occlusion). Women of childbearing potential who are sexually active must agree that they and their partner may use effective contraception during the trial and for 3 months after participation

You may not qualify if:

• Second malignancy in the breast and other organs
• Pregnant or breastfeeding patients
• Planned sentinel lymph node marking using patent blue
• Previous radiation therapy in the area to be examined
• Known or suspected hypersensitivity to the study medication (according to IMPD / SmPC) or other immunoglobulins
• Currently after neoadjuvant (primarily systemic) chemotherapy and anti-hormone therapy
• Immunotherapy (e.g. monoclonal antibodies, cytokines or signal transduction inhibitors) in the last 28 days prior to the declaration of consent
• Previous therapy with bevacizumab
• Planned reconstruction in the breast to be examined
• Previous surgery within the last 28 days prior to the declaration of consent
• Non-healing wounds, ulcers or broken bones within the last 28 days prior to giving informed consent
• Patients with ileus within the last 28 days prior to the declaration of consent
• Non-adjustable hypertension (\> 145/90 mmHg) despite optimal drug therapy
• Insufficient kidney function (serum creatinine\> 1.5 x upper limit of the normal range)
• Current or recent treatment with another investigational drug in another clinical trial within 28 days of informed consent

Sponsors & Collaborators

• Technical University of Munich: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 4, 2022
• Study Start: June 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 4, 2022

Record last verified: 2021-05