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Clinical Trial · NCT02509585
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
Overview
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.
Sponsor
Unknown Organization
Phase
Phase 2
Contacts
Michael Blue, MD (STUDY_DIRECTOR)
ClinicalTrials.gov
NCT02509585Drug / Compound
tilmanocept
Isotope(s):
TECHNETIUM-99m
Radioisotope: Tc-99m
Theranostic Role: SPECT Imaging
T1/2 (Half-Life): 6 Hours
Decay Mode: GAMMA
Energy: 140 keV (89.1%)
Range: N/A
Decay Daughters: Tc99
Status: FDA Approval: First in 1980’s
Target(s):
- Mannose Receptor (CD206/MRC1)
Ligand Class: Small Molecules
Chelator: DTPA
Eligibility
Inclusion
- Has an ECOG performance status of Grade 0 to 2
- Has cervical cancer and is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan.
- 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.
- * Subject has provided written informed consent with HIPAA authorization
- Is at least 18 years of age at the time of consent
Exclusion
- Has had previous surgery or radiation to node basins that would be involved in the ILM procedure
- Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
- Has a known allergy to dextran
- Is breast-feeding or pregnant
- * The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 30 days prior to Lymphoseek administration
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