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

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Brief 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

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 Description

      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.
    

Study Phase

Phase 2

Study Type

Interventional


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)

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)

Condition

Anal Cancer

Intervention

Lymphoseek

Study Arms / Comparison Groups

 Lymphoseek - 0.5 mCi, 50 ug
Description:  A single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99m Tc

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

September 2016

Completion Date

August 2017

Primary Completion Date

August 2017

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Blue, MD, , 



Administrative Informations


NCT ID

NCT02857608

Organization ID

NAV3-20


Responsible Party

Sponsor

Study Sponsor

Cardinal Health 414, LLC


Study Sponsor

Michael Blue, MD, Study Director, Cardinal Health 414, LLC


Verification Date

March 2017