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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymphoseek + Nanocoll | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymphoseek | Drug | 50 μg microgram(s), timepoint: 30-60 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | for at least 48 consecutive hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time frame to ascertain the sentinel nodes | 1 week | |
| Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images. | 1 week | |
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Inclusion Criteria:
Written informed consent
Histologically confirmed diagnosis of melanoma, breast cancer or head and neck cancer and candidate for surgical resection with lymph node mapping being a part of the surgical plan.
At least 18 years of age at the time of consent.
The subject is clinically node negative (cN0) at the time of screening.
In Melanoma Patients
In Breast Cancer Patients
In Oral cavity tumors patients
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico y provincial de Barcelona | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D008545 | Melanoma |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| C431884 | technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran |
| C083602 | technetium Tc 99m nanocolloid |
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| Nanocoll |
| Drug |
500 μg microgram(s), timepoint: 30-60 minutes |
|
| Number of sentinel nodes and secondary nodes depicted |
| 1 week |
| Tracer retention in injection site | 1 week |
| Safety and tolerability of 99mTctilmanocept (Lymphoseek®) | Number of participants with treatment-related adverse events as assessed by Lymphoseek® or with albuminanocolloid | 1 week |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001941 | Breast Diseases |