This phase I trial studies how well Tc-99m tilmanocept detects lymph nodes that drain a brain tumor in patients with suspected benign (non-cancerous) or malignant (cancerous) brain tumors. Tc-99m tilmanocept is a radioactive substance that is used to find lymph nodes by injecting it and then scanning the body with a device that can trace its radioactivity. Imaging Tc-99m tilmanocept may help researchers determine if lymph nodes can be detected how long it takes the Tc-99m tilmanocept to travel from the tumor to the lymph nodes in patients with suspected brain tumors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04096716.
PRIMARY OBJECTIVES:
I. To define the time course of technetium Tc 99m-labeled tilmanocept (Tc-99m tilmanocept) drainage to the lymph nodes from the brain.
II. To use Tc-99m tilmanocept in order to identify and map draining lymph nodes from distinct brain regions using the 2013 international consensus guidelines for cervical and cranial lymph nodes (Gregoire et al, 2013).
OUTLINE: Patients are assigned to 1 of 3 cohorts.
COHORT I: After tumor resection, patients receive technetium Tc 99m-labeled tilmanocept via subcutaneous (SC), intradermal (ID), subareolar or peritumoral injection. Patients then undergo imaging via handheld gamma probe and/or portable planar imaging at 4.5 hours and 24 hours after injection.
COHORT II: Patients are assigned to 1 of 4 sub-cohorts.
COHORT IIA (COHORT CLOSED): After tumor resection, patients receive technetium Tc 99m-labeled tilmanocept via SC, ID, subareolar or peritumoral injection to the frontal lobe injection site. Patients then undergo a single photon emission computed tomography (SPECT)/computed tomography (CT) scan on day 1 or 2.
COHORT IIB (COHORT CLOSED): After tumor resection, patients receive technetium Tc 99m-labeled tilmanocept via SC, ID, subareolar or peritumoral injection to the parietal lobe injection site. Patients then undergo a SPECT/CT scan on day 1 or 2.
COHORT IIC (COHORT CLOSED): After tumor resection, patients receive technetium Tc 99m-labeled tilmanocept via SC, ID, subareolar or peritumoral injection to the temporal lobe injection site. Patients then undergo a SPECT/CT scan on day 1 or 2.
COHORT IID: After tumor resection, patients receive technetium Tc 99m-labeled tilmanocept via SC, ID, subareolar or peritumoral injection to the occipital lobe injection site. Patients then undergo a SPECT/CT scan on day 1 or 2.
COHORT III: After tumor resection, patients undergo SPECT/CT scan on day 1 or 2.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorTanner M. Johanns
