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

Cardinal Health

Status and phase

Withdrawn

Phase 2

Conditions

Anal Cancer

Treatments

Drug: Lymphoseek

Study type

Interventional

Funder types

Industry

Identifiers

NCT02857608

NAV3-20

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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