Evaluation of the Oral 18FFTHA Tracer for PETCT Imaging of the Intestinal and Central Lymphatic System in Adults with Suspected Thoracic Duct Obstruction

What this Trial Is About

Researchers are studying a new imaging tracer called 18FFTHA to visualize the intestinal and central lymphatic system in adults. The project spans about two years, starting with development and testing of the tracer on healthy volunteers, followed by investigation in patients suspected of having obstruction in the thoracic duct TD, a key lymphatic vessel. This early phase 1 study aims to better understand lymphatic system function and obstruction using this novel imaging technique. Participants will receive an oral dose of the 18FFTHA tracer in capsule form, followed by several whole-body PETCT scans over approximately four hours with breaks between scans. Initially, up to 10 healthy adults will undergo this single tracer administration and imaging session. Subsequently, about 15 patients with symptoms like chronic abdominal pain and edema suspected to be due to TD obstruction will undergo the same procedure. Some patients who undergo clinical surgical bypass for their condition will be invited back for a follow-up PETCT scan after surgery. During the study, participants will fast overnight before imaging and consume an Ensure drink after tracer administration. Researchers will monitor tracer transit time and radiation dosimetry over the following weeks. Safety assessments include pregnancy testing for women of childbearing potential and evaluation of ability to tolerate imaging. The total study participation period is about two years, with imaging visits scheduled on study days and follow-up imaging for surgical patients as applicable.

18F-FTHA IMAGING OF THE INTESTINAL AND CENTRAL LYMPHATIC SYSTEM