title: [(99m)Tc]Tilmanocept Accurately Detects Sentinel Lymph Nodes and Predicts Node Pathology Status in Patients with Oral Squamous Cell Carcinoma of the Head and Neck: Results of a Phase III Multi-institutional Trial.
abstract: BACKGROUND
  [(99m)Tc]Tilmanocept, a novel CD206 receptor-targeted radiopharmaceutical, was evaluated in an open-label, phase III trial to determine the false negative rate (FNR) of sentinel lymph node biopsy (SLNB) relative to the pathologic nodal status in patients with intraoral or cutaneous head and neck squamous cell carcinoma (HNSCC) undergoing tumor resection, SLNB, and planned elective neck dissection (END). Negative predictive value (NPV), overall accuracy of SLNB, and the impact of radiopharmaceutical injection timing relative to surgery were assessed.
  
  
  RESULTS
  This multicenter, non-randomized, single-arm trial (ClinicalTrials.gov identifier NCT00911326) enrolled 101 patients with T1-T4, N0, and M0 HNSCC. Patients received 50 µg [(99m)Tc]tilmanocept radiolabeled with either 0.5 mCi (same day) or 2.0 mCi (next day), followed by lymphoscintigraphy, SLNB, and END. All excised tissues were evaluated for tissue type and tumor presence. [(99m)Tc]Tilmanocept identified one or more SLNs in 81 of 83 patients (97.6 %). Of 39 patients identified with any tumor-positive nodes (SLN or non-SLN), one patient had a single tumor-positive non-SLN in whom all SLNs were tumor-negative, yielding an FNR of 2.56 %; NPV was 97.8 % and overall accuracy was 98.8 %. No significant differences were observed between same-day and next-day procedures.
  
  
  CONCLUSIONS
  Use of receptor-targeted [(99m)Tc]tilmanocept for lymphatic mapping allows for a high rate of SLN identification in patients with intraoral and cutaneous HNSCC. SLNB employing [(99m)Tc]tilmanocept accurately predicts the pathologic nodal status of intraoral HNSCC patients with low FNR, high NPV, and high overall accuracy. The use of [(99m)Tc]tilmanocept for SLNB in select patients may be appropriate and may obviate the need to perform more extensive procedures such as END.
authors: Department of Otolaryngology-Head and Neck Surgery, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University Wexner Medical Center, Columbus, OH, USA. amit.agrawal@osumc.edu.
authors: Amit
authors: A
authors: Agrawal
authors: Department of Otolaryngology, University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center, Miami, FL, USA.
authors: Francisco J
authors: FJ
authors: Civantos
authors: Division of Head and Neck Surgery, Department of Surgery, Moores UCSD Cancer Center and Veteran Affairs San Diego Medical Center, San Diego, CA, USA.
authors: Kevin T
authors: KT
authors: Brumund
authors: Department of Otolaryngology, University of Toronto, Toronto, ON, Canada.
authors: Douglas B
authors: DB
authors: Chepeha
authors: Division of Nuclear Medicine, Department of Radiology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
authors: Nathan C
authors: NC
authors: Hall
authors: Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.
authors: William R
authors: WR
authors: Carroll
authors: Department of Otolaryngology-Head and Neck Surgery, University of Nebraska Medical Center, Omaha, NE, USA.
authors: Russell B
authors: RB
authors: Smith
authors: Department of Otolaryngology-Head and Neck Surgery, University of Missouri, Columbia, MO, USA.
authors: Robert P
authors: RP
authors: Zitsch
authors: Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, Duke University Medical Center, Durham, NC, USA.
authors: Walter T
authors: WT
authors: Lee
authors: Department of Otolaryngology-Head and Neck Surgery, University of Kansas Medical Center, Kansas City, KS, USA.
authors: Yelizaveta
authors: Y
authors: Shnayder
authors: Department of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA, USA.
authors: David M
authors: DM
authors: Cognetti
authors: Banner MD Anderson Cancer Specialists, Gilbert, AZ, USA.
authors: Karen T
authors: KT
authors: Pitman
authors: STATKING Clinical Services, Fairfield, OH, USA.
authors: Dennis W
authors: DW
authors: King
authors: STATKING Clinical Services, Fairfield, OH, USA.
authors: Lori A
authors: LA
authors: Christman
authors: Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors: Stephen Y
authors: SY
authors: Lai
mesh_terms: D002294:Carcinoma, Squamous Cell / Q000000981:diagnostic imaging* / Q000556:secondary / Q000601:surgery; D003911:Dextrans / Q000008:administration & dosage; D005188:False Negative Reactions; D006801:Humans; D008198:Lymph Nodes / Q000000981:diagnostic imaging* / Q000473:pathology; D008207:Lymphatic Metastasis; D061305:Lymphoscintigraphy / Q000379:methods; D008351:Mannans / Q000008:administration & dosage; D009062:Mouth Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology / Q000601:surgery; D009333:Neck; D037981:Neck Dissection; D011237:Predictive Value of Tests; D019275:Radiopharmaceuticals / Q000008:administration & dosage; D021701:Sentinel Lymph Node Biopsy; D016284:Technetium Tc 99m Pentetate / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015899:Tomography, Emission-Computed, Single-Photon
chemical_list: D003911:Dextrans; D008351:Mannans; D019275:Radiopharmaceuticals; C431884:technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran; D016284:Technetium Tc 99m Pentetate