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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 (DoT-FMI)

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bevacizumab-IRDye800CW
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Potentially fertile women without adequate contraception. Safe contraceptive measures are procedures with a Pearl index of ≤ 1%
  • Patients with other serious illnesses that pose an unreasonable risk for participating in the study
  • Persons who are in a dependent / employment relationship with the sponsor or investigator
  • Persons who are to be or are to be accommodated in an institution due to a court or official order

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    treatment arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Safety and Toxicity of Bevacizumab-IRDye800CW will be analyzed by absolute and relative frequencies of Safety events
    Absolute and relative frequencies of AE, SAE, AR, and SAR are presented by MedDRA System Organ Class and Preferred Term.

    Full Information

    First Posted
    May 14, 2021
    Last Updated
    April 28, 2022
    Sponsor
    Technical University of Munich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05359874
    Brief Title
    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
    Acronym
    DoT-FMI
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    application has been withdrawn
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Technical University of Munich

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment arm
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab-IRDye800CW
    Other Intervention Name(s)
    Device: special multispectral fluorescence-reflecting cameras
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Determination of the sensitivity and specificity of bevacizumab- IRDye800CW
    Description
    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
    Time Frame
    21 days
    Secondary Outcome Measure Information:
    Title
    Safety and Toxicity of Bevacizumab-IRDye800CW will be analyzed by absolute and relative frequencies of Safety events
    Description
    Absolute and relative frequencies of AE, SAE, AR, and SAR are presented by MedDRA System Organ Class and Preferred Term.
    Time Frame
    21 days

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 Potentially fertile women without adequate contraception. Safe contraceptive measures are procedures with a Pearl index of ≤ 1% Patients with other serious illnesses that pose an unreasonable risk for participating in the study Persons who are in a dependent / employment relationship with the sponsor or investigator Persons who are to be or are to be accommodated in an institution due to a court or official order

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    no patient specific data will be shared

    Learn more about this trial

    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

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