Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer

Study Overview
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Brief Summary
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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

Official Title
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An Exploratory Prospective, Open-label, Unicentric Study With Cross-over Design, Comparing Lymphoseek® vs. Albumin Nanocolloid for Image- Guided Sentinel Lymph Node Mapping in Head and Neck, Melanoma and Breast Cancer.

Conditions
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Head Cancer, Neck Cancer, Melanoma, Breast Cancer

Intervention / Treatment
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* Drug: Lymphoseek
* Drug: Nanocoll


Participation Criteria
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Eligibility Criteria
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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 Diagnosis of primary melanoma with sentinel node indication ( >0.8 mm Breslow thickness; clinically negative lymph nodes) In Breast Cancer Patients T1-T2 N0 breast cancer. Patients with pure ductal carcinoma in situ (DCIS) if lymph node biopsy is part of the surgical plan. In Oral cavity tumors patients T1-T2 N0 oral cavity squamous cell carcinoma Exclusion Criteria: Pregnancy or lactation Clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary tumor Patients who have undergone a wide excision for their tumor or complex reconstruction (rotation, free flap or skin graft of any type).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lymphoseek + Nanocoll<br>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 | Drug: Lymphoseek<br>* 50 μg microgram(s), timepoint: 30-60 minutes<br>Drug: Nanocoll<br>* 500 μg microgram(s), timepoint: 30-60 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |