Clinical Trial · NCT02857608

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

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Michael Blue, MD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT02857608

Drug / Compound

Tilmanocept

Isotope(s):

Target(s):

Mannose Receptor (CD206/MRC1)

Ligand Class: Small Molecules

Chelator: DTPA

Eligibility

Inclusion

* Subject has provided written informed consent with Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization
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
Has histologically confirmed squamous cell carcinoma of the anus (anal canal or perianus)

Exclusion

Is breast-feeding or pregnant
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
Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
Has a known allergy to dextran
* The subject has had radiation therapy, chemotherapy or immunotherapy within the 30 days prior to Lymphoseek administration