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Detection of breast carcinoma with an ICG enhanced optical imaging device in breast cancer patients.

Completed
Conditions
breast cancer
lumpectomy
10006291
10006295
Registration Number
NL-OMON33137
Lead Sponsor
niversitair Medisch Centrum Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
10
Inclusion Criteria

Women above the age of 21 who have biopsy-proven breast cancer stage I-II who are undergoing lumpectomy

Exclusion Criteria

Pregnant women, significant renal, cardiac or pulmonary disease, history of iodine allergy or anaphylactic reactinos to insect bites or medication, presence or history of hyperthyroidism

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary Objective:<br /><br>* Ergonomics and function of the imaging system - the NIRF imaging system<br /><br>should not interfere with the standard lumpectomy procedure and be used safely<br /><br>by the surgeon while detection of ICG takes place. Duration: 1,5 hour clinical<br /><br>procedure </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>none</p><br>
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