Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
26 participants
INTERVENTIONAL
2015-10-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Part 1
In part 1 a dose escalation will be performed for the tracer bevacizumab-800CW in four different dose groups (4,5mg 10mg 25mg 50mg)
Bevacizumab-800CW
three days prior to surgery bevacizumab-800CW will be administered
Part 2
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.
Bevacizumab-800CW
three days prior to surgery bevacizumab-800CW will be administered
Interventions
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Bevacizumab-800CW
three days prior to surgery bevacizumab-800CW will be administered
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery.
3. Tumor size ≥ 5 mm (0, 5 cm) diameter according to anatomical imaging data.
4. WHO performance score 0-2.
5. Life expectancy greater than 12 weeks
6. Written informed consent has been obtained
7. 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:
8. A negative serum pregnancy test prior to receiving the second generation tracer
9. Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.
Exclusion Criteria
2. Breast prosthesis in the target breast
3. History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
4. Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment
5. Significant renal or hepatic impairment.
6. Inadequately controlled hypertension with or without current antihypertensive medications.
7. 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.
8. Patients receiving anticoagulant therapy with vitamin K antagonists.
9. Patients receiving Class IA (e.g. Quinidine) or Class III (e.g. Dofetilide, Amiodarone, Sotalol) antiarrhythmic agents.
10. Evidence of QT prolongation on pre-treatment ECG (Males \>440 ms, Females \>450 ms).
11. Magnesium, potassium and calcium levels below lower normal limit which is regarded clinically relevant with regards to study participation.
18 Years
FEMALE
No
Sponsors
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Martini Hospital Groningen
OTHER
University Medical Center Groningen
OTHER
Responsible Party
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G.M. van Dam
prof.dr.
Principal Investigators
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G.M van Dam, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
UMCG
Locations
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University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
Countries
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Other Identifiers
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NL52447.042.15
Identifier Type: -
Identifier Source: org_study_id
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