A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus

Study Overview
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Brief Summary
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Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus.

Detailed Description
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Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99mTc.

Official Title
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A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus

Conditions
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Anal Cancer

Intervention / Treatment
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* Drug: Lymphoseek


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided written informed consent with Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization Has histologically confirmed squamous cell carcinoma of the anus (anal canal or perianus) Has a documented clinical stage using the tumor, lymph node, metastasis staging (TNM) classification system that was established by at least physical exam with manual palpation, digital anorectal examination, high-resolution anoscopy and PET/CT imaging evaluation of the bilateral inguinal area Is at least 18 years of age at the time of consent Has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 3 If of childbearing potential, the subject has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year Exclusion Criteria: The subject has had radiation therapy, chemotherapy or immunotherapy within the 30 days prior to Lymphoseek administration Has had previous surgery or node dissection (exclusive of fine needle aspiration) or radiation to node basins that would be involved in the intraoperative lymphatic mapping procedure Has a known allergy to dextran Is breast-feeding or pregnant Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical Has received an investigational product within the 30 days prior to Lymphoseek administration

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 |
| --- | --- |
| Experimental: Lymphoseek - 0.5 mCi, 50 ug<br>A single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99m Tc | Drug: Lymphoseek<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by standard of care methods) |  | 2-5 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reverse Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by Lymphoseek) |  | 2-5 Days | 
| Nodal Concordance (the proportion of the number lymph nodes identified by Lymphoseek and standard of care methods compared to the number of lymph nodes identified by standard of care methods) |  | 2-5 Days | 
| Reverse Nodal Concordance (the proportion of the number lymph nodes identified by Lymphoseek and standard of care methods compared to the number of lymph nodes identified by Lymphoseek) |  | 2-5 Days | 
| Incidence of Adverse Events |  | 5 Days |