Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
50 μg microgram(s), timepoint: 30-60 minutes
500 μg microgram(s), timepoint: 30-60 minutes
Hospital Clínico y provincial de Barcelona
Barcelona, Spain
Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies
number and diameter in millimeters of nodes affected identified by 99mTc-tilmanocept vs nanocolloidal
Time frame: for at least 48 consecutive hours
Time frame to ascertain the sentinel nodes
Time frame: 1 week
Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images.
Time frame: 1 week
Number of sentinel nodes and secondary nodes depicted
Time frame: 1 week
Tracer retention in injection site
Time frame: 1 week
Safety and tolerability of 99mTctilmanocept (Lymphoseek®)
Number of participants with treatment-related adverse events as assessed by Lymphoseek® or with albuminanocolloid
Time frame: 1 week
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