Trial details
A Feasibility Trial of Lymphatic Mapping with SPECT-CT for Evaluating Contralateral Disease in Lateralized Oropharynx Cancer using 99m-Technetium Sulfur Colloid
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Trial short name: SPECT-CT
Official title: A Feasibility Trial of Lymphatic Mapping with SPECT-CT for Evaluating Contralateral Disease in Lateralized Oropharynx Cancer using 99m-Technetium Sulfur Colloid
Principal Investigator: Dr. Antoine Eskander
Cancer type: Head & Neck
Cancer location: Head & Neck
Disease stage: Early Cancer
Trial phase: Phase 3
Intervention:
Registration #:
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
A phase III trial comparing a lymphatic mapping guided approach vs. bilateral neck treatment. Prior to large-scale evaluation, the objective of this study is to demonstrate feasibility of injection in patients in a multi-institutional study. Patients will undergo injections of a radiotracer, 99m-Technetium Sulfur Colloid, around the primary tumor in 4-6 quadrants either with local anesthesia or under general anesthesia. Primary objective is to demonstrate multi-institutional feasibility of injection of 99m-Technetium Sulfur Colloid in patients with lateralized oropharyngeal cancer
Inclusion criteria: -Patient has lateralized oropharyngeal carcinoma (tonsil or tongue base) not involving midline; -Has squamous cell carinoma, T1-3 tumors, with no contralateral nodes on clinical exam or axial imaging (CT or MRI); -HPV positive or negative; -Normal organ function as per investigator judgement; -Patient planned for definitive or adjuvant RT or CRT with bilateral neck RT, or surgery; -Age 18 or older; -ECOG 0-1. Exclusion criteria: -T4 tumors; -Contralateral/bilateral nodal disease or node(s) >6cm on clinical exam or axial imaging or PET; -Primary tumor involving or crossing midline; -Soft palate or posterior pharyngeal wall tumor subsites
