Breast CancerPhase 1/2MARGINNCT02583568
Fluorescence Guided Surgery in Breast Cancer
A Phase 1/2 study testing Bevacizumab-800CW in people with Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
A need for further investigation for fluorescence image-guided surgery in breast conserving surgery (BCS) has arisen following the results obtained from a phase I feasibility breast cancer trial (BIRDYE study: ABR NL 37479.042011). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bevacizumab-800CW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2015to Feb 2017
- Phase
- Phase 1/2
- 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
Main Inclusion Criteria:
- Females aged ≥ 18 years.
- Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery.
- Tumor size ≥ 5 mm (0, 5 cm) diameter according to anatomical imaging data.
- WHO performance score 0-2.
- Life expectancy greater than 12 weeks
- Written informed consent has been obtained
- In the Investigator's opinion, patient is able and willing to comply with all trial requirements. For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:
- A negative serum pregnancy test prior to receiving the second generation tracer
- Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.
Main Exclusion Criteria:
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Breast prosthesis in the target breast
- History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
- Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment
- Significant renal or hepatic impairment.
- Inadequately controlled hypertension with or without current antihypertensive medications.
- History of myocardial infarction, transient ischemic attack, cerebro vascular accident, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment.
- Patients receiving anticoagulant therapy with vitamin K antagonists.
- Patients receiving Class IA (e.g. Quinidine) or Class III (e.g. Dofetilide, Amiodarone, Sotalol) antiarrhythmic agents.
- Evidence of QT prolongation on pre-treatment ECG (Males >440 ms, Females >450 ms).
- Magnesium, potassium and calcium levels below lower normal limit which is regarded clinically relevant with regards to study participation.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9713 GZ
About this study
Official title: Phase II, Open-Label Study to Evaluate Safety and Explore Efficacy of Escalating Doses of Bevacizumab-IRDye800CW as an Optical Imaging Agent to Detect Cancer Tissue Delineation During Tumor Resection Surgery in Patients With Breast Cancer
A need for further investigation for fluorescence image-guided surgery in breast conserving surgery (BCS) has arisen following the results obtained from a phase I feasibility breast cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation of breast cancer tissue using the improved and optimized fluorescent tracer and camera system.
- Conditions
- Breast Cancer
- Being tested
- Bevacizumab-800CW
- Keywords
- breast cancer, image-guided surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab-800CWDrug
Also called Bevacizumab-IRDye800CW
three days prior to surgery bevacizumab-800CW will be administered
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | In part 1 a dose escalation will be performed for the tracer bevacizumab-800CW in four different dose groups (4,5mg 10mg 25mg 50mg) Receives: Drug: Bevacizumab-800CW |
| Part 2 | Experimental | In part 2, the two best performing dose groups of bevacizumab-800CW of part 1 will be expanded to a total of 10 patients per group. Receives: Drug: Bevacizumab-800CW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor-to-background ratio
Measured: day 3
Secondary outcomes (1)
Number of participants with treatment-related adverse events
Measured: up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2017
- Study completionFeb 2017
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.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Martini Hospital Groningen
- Responsible party
- Principal investigator, G.M. van Dam, University Medical Center Groningen
- Investigators
- G.M van Dam, prof. dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583568
- Sponsor's protocol ID
- NL52447.042.15
- Acronym
- MARGIN
- Status last verified
- Feb 2017
- First submitted
- 30 Jun 2015
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open-Label Study to Evaluate Safety and Explore Efficacy of Escalating Doses of Bevacizumab-IRDye800CW as an Optical Imaging Agent to Detect Cancer Tissue Delineation During Tumor Resection Surgery in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT02583568
- Acronym / sponsor ID
- MARGIN / NL52447.042.15
- Conditions
- Breast Cancer
- Keywords
- breast cancer, image-guided surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Martini Hospital Groningen
- Study start
- Oct 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 22 Oct 2015 (estimated)
- 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.
A need for further investigation for fluorescence image-guided surgery in breast conserving surgery (BCS) has arisen following the results obtained from a phase I feasibility breast cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation of breast cancer tissue using the improved and optimized fluorescent tracer and camera system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Bevacizumab-800CWIn part 1 a dose escalation will be performed for the tracer bevacizumab-800CW in four different dose groups (4,5mg 10mg 25mg 50mg) |
| Part 2 | Experimental | Drug: Bevacizumab-800CWIn part 2, the two best performing dose groups of bevacizumab-800CW of part 1 will be expanded to a total of 10 patients per group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Bevacizumab-800CWAlso: Bevacizumab-IRDye800CWthree days prior to surgery bevacizumab-800CW will be administered | Drug | Part 1, Part 2 |
Primary outcome
Tumor-to-background ratio
Time frame: day 3
1 secondary outcome
Number of participants with treatment-related adverse events
Time frame: up to two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
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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.
G.M van Dam, prof. dr. principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bevacizumab-800CW in people with Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor-to-background ratio (time frame: day 3). 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 13 Feb 2017.