Breast CancerMARGIN-2NCT05939310
Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study
A study testing Fluorescence guided detection of tumor positive margins. in people with Breast Cancer and Breast Cancer Invasive, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Invasive
- What is being tested?
- Fluorescence guided detection of tumor positive margins.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jan 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713GZ
Pieter J van der Zaag, +31 50 3616161, p.j.van.der.zaag@umcg.nl
- Recruiting
Martini Ziekenhuis
Groningen, 9728NT
Wendy Kelder, +31 50 5245245, w.kelder@mzh.nl
About this study
Official title: Improving Radical Resection Rates in Patients With Breast Cancer by Intraoperative Imaging Using Bevacizumab-IRDye800CW - the MARGIN-2 Study
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.
- Conditions
- Breast Cancer, Breast Cancer Invasive
- Being tested
- Fluorescence guided detection of tumor positive margins.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence guided detection of tumor positive margins.Procedure or surgery
Intraoperative fluorescence imaging detection of tumor positive margins using the targeted tracer bevacizumab-IRDye800CW.
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence guided surgery | Experimental | 10 mg bevacizumab-IRDye800CW, to intraoperatively assess possible tumour-positive margins. Receives: Procedure: Fluorescence guided detection of tumor positive margins. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
Detection ex-vivo imaging
To determine whether ex-vivo fluorescence imaging can adequately show tumor-positive margins in resected tissue samples.
Measured: 1 year
Detection in-vivo imaging
To determine whether in-vivo fluorescence imaging can adequately show residual tumor in the cavity.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Jan 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Martini Hospital Groningen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939310
- Sponsor's protocol ID
- 10975
- Acronym
- MARGIN-2
- Status last verified
- Apr 2024
- First submitted
- 3 Jul 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Radical Resection Rates in Patients With Breast Cancer by Intraoperative Imaging Using Bevacizumab-IRDye800CW - the MARGIN-2 Study
- ClinicalTrials.gov ID
- NCT05939310
- Acronym / sponsor ID
- MARGIN-2 / 10975
- Conditions
- Breast Cancer, Breast Cancer Invasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Martini Hospital Groningen
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescence guided surgery | Experimental | Procedure: Fluorescence guided detection of tumor positive margins.10 mg bevacizumab-IRDye800CW, to intraoperatively assess possible tumour-positive margins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescence guided detection of tumor positive margins.Intraoperative fluorescence imaging detection of tumor positive margins using the targeted tracer bevacizumab-IRDye800CW. | Procedure or surgery | Fluorescence guided surgery |
Primary outcome
Detection
Time frame: 1 year
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.
3 secondary outcomes
Detection ex-vivo imaging
Time frame: 1 year
Detection in-vivo imaging
Time frame: 1 year
Radical resection rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescence guided detection of tumor positive margins. in people with Breast Cancer and Breast Cancer Invasive, run by University Medical Center Groningen at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.