[18F]FTHA Imaging for Lymphedema
(FTHA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The project will be performed over a period of approximately two years. In the first year the \[18F\]FTHA tracer will be developed, optimized, and tested on normal volunteers. During the second year, the tracer will be investigated on patients with suspected obstruction of the thoracic duct (TD).
Are You a Good Fit for This Trial?
This trial is for adults aged 18 and older. It includes healthy volunteers in good general health, as well as patients suspected of having a blockage in the thoracic duct (a major lymphatic vessel). Some stable chronic conditions may be allowed if they don't affect imaging.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Tracer Development and Testing
Development, optimization, and testing of the [18F]FTHA tracer on healthy volunteers
Patient Imaging
Investigation of the tracer on patients with suspected obstruction of the thoracic duct
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study is testing a new imaging method using an injected tracer called [18F]FTHA with PET/CT scans to visualize the intestinal and central lymphatic system. First, it will be tried on healthy people, then on patients with possible lymphatic blockages.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients with known or suspected obstruction of the thoracic duct (TD)-venous junction will undergo a single injection of \[18F\]-FTHA (a long-chain fatty acid positron emitting radiotracer) followed by up to 4 PET/CT scans. If the patient undergoes a clinical surgical procedure then they will be asked to undergo a second \[18F\]FTHA PET/Ct scan following the same procedure as the baseline scan.
Healthy volunteers will undergo a single injection of \[18F\]-FTHA (a long-chain fatty acid positron emitting radiotracer) followed by up to 4 PET/CT scans.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
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