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Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study (MARGIN-2)

Primary Purpose

Breast Cancer, Breast Cancer Invasive

Status
Not yet recruiting
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Fluorescence guided detection of tumor positive margins.
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

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

Inclusion Criteria: Patients are females with histologically proven carcinoma of the breast The carcinoma of the breast is a local disease with limited size (but tumor size ≥ 0.5cm) and in the multidisciplinary tumor board meeting breast conserving therapy is advised. Age ≥ 18 years Written informed consent has been obtained Women of childbearing potential (premenopausal women with intact reproductive organs and women less than two years after menopause) require use of effective contraception at least 3 months before administration of the tracer (if not, a negative serum pregnancy test has to be submitted), and they need to be willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter. Exclusion Criteria: Medical or psychiatric conditions that compromise the patient's ability to give informed consent Non palpable breast tumor or prior surgery of this breast Received an investigational drug within 30 days prior to bevacizumab-IRDye800CW History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure or unstable angina within 6 months prior to enrollment Inadequately controlled hypertension with or without current antihypertensive medication Significant renal or hepatic impairment (grade II or higher deviations by CTCAE) History of allergy or infusion reactions bevacizumab or other monoclonal antibodies Pregnant or lactating women Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents Life expectancy < 12 weeks Preoperatively undetectable lymph nodes using SPECT-scan, requiring the use of patent blue

Sites / Locations

  • University Medical Center Groningen
  • Martini Ziekenhuis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluorescence guided surgery

Arm Description

10 mg bevacizumab-IRDye800CW, to intraoperatively assess possible tumour-positive margins.

Outcomes

Primary Outcome Measures

Detection
To determine whether real-time tumor visualization using targeted fluorescent imaging during breast conserving therapy in breast cancer patients can be achieved intraoperatively and results in adequate assessment of the tumor margin.

Secondary Outcome Measures

Detection ex-vivo imaging
To determine whether ex-vivo fluorescence imaging can adequately show tumor-positive margins in resected tissue samples.
Detection in-vivo imaging
To determine whether in-vivo fluorescence imaging can adequately show residual tumor in the cavity.
Radical resection rate
To analyze whether patients that in standard-of-care would have tumor-positive margins and needed additional treatment postoperatively, had a radical resection after biopsy using fluorescence guided surgery.

Full Information

First Posted
July 3, 2023
Last Updated
July 10, 2023
Sponsor
University Medical Center Groningen
Collaborators
Martini Ziekenhuis
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1. Study Identification

Unique Protocol Identification Number
NCT05939310
Brief Title
Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study
Acronym
MARGIN-2
Official Title
Improving Radical Resection Rates in Patients With Breast Cancer by Intraoperative Imaging Using Bevacizumab-IRDye800CW - the MARGIN-2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen
Collaborators
Martini Ziekenhuis

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
The goal of this clinical trial is to intraoperatively visualize tumour tissue in breast cancer patients using fluorescence imaging with the tracer bevacizumab-IRDye800CW and thereby enhance real-time clinical decision making, preventing postoperative tumour-positive margins.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluorescence guided surgery
Arm Type
Experimental
Arm Description
10 mg bevacizumab-IRDye800CW, to intraoperatively assess possible tumour-positive margins.
Intervention Type
Procedure
Intervention Name(s)
Fluorescence guided detection of tumor positive margins.
Intervention Description
Intraoperative fluorescence imaging detection of tumor positive margins using the targeted tracer bevacizumab-IRDye800CW.
Primary Outcome Measure Information:
Title
Detection
Description
To determine whether real-time tumor visualization using targeted fluorescent imaging during breast conserving therapy in breast cancer patients can be achieved intraoperatively and results in adequate assessment of the tumor margin.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Detection ex-vivo imaging
Description
To determine whether ex-vivo fluorescence imaging can adequately show tumor-positive margins in resected tissue samples.
Time Frame
1 year
Title
Detection in-vivo imaging
Description
To determine whether in-vivo fluorescence imaging can adequately show residual tumor in the cavity.
Time Frame
1 year
Title
Radical resection rate
Description
To analyze whether patients that in standard-of-care would have tumor-positive margins and needed additional treatment postoperatively, had a radical resection after biopsy using fluorescence guided surgery.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients are females with histologically proven carcinoma of the breast The carcinoma of the breast is a local disease with limited size (but tumor size ≥ 0.5cm) and in the multidisciplinary tumor board meeting breast conserving therapy is advised. Age ≥ 18 years Written informed consent has been obtained Women of childbearing potential (premenopausal women with intact reproductive organs and women less than two years after menopause) require use of effective contraception at least 3 months before administration of the tracer (if not, a negative serum pregnancy test has to be submitted), and they need to be willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter. Exclusion Criteria: Medical or psychiatric conditions that compromise the patient's ability to give informed consent Non palpable breast tumor or prior surgery of this breast Received an investigational drug within 30 days prior to bevacizumab-IRDye800CW History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure or unstable angina within 6 months prior to enrollment Inadequately controlled hypertension with or without current antihypertensive medication Significant renal or hepatic impairment (grade II or higher deviations by CTCAE) History of allergy or infusion reactions bevacizumab or other monoclonal antibodies Pregnant or lactating women Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents Life expectancy < 12 weeks Preoperatively undetectable lymph nodes using SPECT-scan, requiring the use of patent blue
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713GZ
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter J van der Zaag
Phone
+31 50 3616161
Email
p.j.van.der.zaag@umcg.nl
Facility Name
Martini Ziekenhuis
City
Groningen
ZIP/Postal Code
9728NT
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Kelder
Phone
+31 50 5245245
Email
w.kelder@mzh.nl

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study

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