A Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection

Cardinal Health

Status and phase: Terminated; Phase 2

Conditions: Uterine Cervical Neoplasms

Treatments: Drug: Tc99m tilmanocept

Study type: Interventional

Funder types: Industry

Identifiers

NCT02509585

NAV3-19

Details and patient eligibility

About

Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has provided written informed consent with HIPAA authorization
• Has cervical cancer and is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan.
• Is at least 18 years of age at the time of consent
• Has an ECOG performance status of Grade 0 to 2
• Has the following International Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1staging. Subjects with a single enlarged/suspicious node on PET/CT will still be considered eligible as consistent with FIGO guidelines.
• 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 preoperative chemotherapy, immunotherapy, or radiation therapy within the 30 days prior to Lymphoseek administration
• Has had previous surgery or radiation to node basins that would be involved in the ILM 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
• Is scheduled for surgery and/or another invasive procedure other than the primary surgical intervention within the 3 days after Lymphoseek administration
• Has received an investigational product within the 30 days prior to Lymphoseek administration

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

Tc99m tilmanocept

Experimental group

Description:

2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration

Treatment:

Drug: Tc99m tilmanocept