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

NCT02857608 | Withdrawn Phase 2

• 1 other identifier: NAV3-20
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Lymphoseek - 0.5 mCi, 50 ug

EXPERIMENTAL

A single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99m Tc

Drug: Lymphoseek

Interventions

Lymphoseek DRUG

Lymphoseek - 0.5 mCi, 50 ug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardinal Health 414, LLC: lead

MeSH Terms

Conditions

Anus Neoplasms

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Officials

• Michael Blue, MD

  Cardinal Health 414, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 5, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share