Clinical Trial: 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Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: 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

Brief Summary: 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 Summary: 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.
Sponsor: Cardinal Health 414, LLC

Current Primary Outcome: 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) [ Time Frame: 2-5 Days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 2-5 Days ]
  • Incidence of Adverse Events [ Time Frame: 5 Days ]


Original Secondary Outcome: Same as current

Information By: Cardinal Health 414, LLC

Dates:
Date Received: August 2, 2016
Date Started: September 2016
Date Completion: August 2017
Last Updated: March 13, 2017
Last Verified: March 2017