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INTRAOPERATIVE REAL TIME IMAGING WITH A DUAL RADIOACTIVE/FLUORESCENCE MODALITY FOR SENTINEL NODE LOCALIZATION. A FEASIBILITY STUDY INCLUDING REPRODUCIBILITY OF MULTIMODALITY LYMPHATIC MAPPING WITH A COCKTAIL TRACER CONTAINING 99mTc NANOCOLLOID /ICG

Conditions
malignancy
10027655
Registration Number
NL-OMON33218
Lead Sponsor
Antoni van Leeuwenhoek Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

Patients presenting cutaneous melanoma of head/neck and upper part of the trunk
Patients presenting oral cavity malignances T1-2N0
Breast cancer patients with a medially located tumor (palpable tumors and non-palpable tumors detectable by ultrasound) with demonstrated drainage outside the axilla
Patients with clinical N0 stage

Exclusion Criteria

Evidence of regional or distant metastases
Non-palpable breast tumors requiring stereotaxis for tracer administration
Incapacity or unwillingness of participant to give written informed consent
Allergy to iodides

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>1.number and location of sentinel nodes after 99mTc-nanocolloid injection<br /><br>2.number and location of sentinel nodes after cocktail injection<br /><br>3.different locations and number of sentinel nodes after first injection<br /><br>4.surgical retrieval rate and procedure time</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>None</p><br>
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