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Luke Nordquist, MD, FACP, CEO
drluke@xcancer.comTony Romero, MS, CCRC, Director of Research
tromero@gucancer.comA Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus
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.
Sponsor:
Unknown Organization
Phase:
Phase 2
Contacts:
Michael Blue, MD (STUDY_DIRECTOR)Government Study Link:
NCT02857608 - Click here to see study onClinicalTrials.gov
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
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
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