18F-FTHA IMAGING OF THE INTESTINAL AND CENTRAL LYMPHATIC SYSTEM
ConditionLymphatic Obstruction
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About 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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male and female participants will be ≥ 18 years of age.
"Healthy Volunteer" is defined for the purposes of this study as a volunteer who is in good general health in the opinion of an investigator (some well controlled chronic medical conditions may be allowed at the discretion of an investigator if they do not believe they will interfere with the collection of imaging data, specific excluded medical conditions are listed under
Disqualifiers
Informed of the investigational nature of this study and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Male and female participants will be ≥ 18 years of age
Informed of the investigational nature of this study and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Patient with chronic abdominal pain, ascites protein losing enteropathy, as well edema, with clinically suspected obstruction of the TD-venous junction and who are candidates for TD-venous junction plasty and or TD-Venous bypass
Trial design
Design model
Single group
Treatments tested in this trial
[18F]FTHA PET/CT scan
Diagnostic testPositron Emission Tomography/Computed Tomography (PET/CT) scans
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Healthy VolunteerExperimental treatment 1 intervention
Group B: TD-Venous Obstruction patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
FTHA transit time
To determine the normal \[18F-\]FTHA transit times through the intestinal lymphatic system, and TD among healthy human subjects imaged on a whole body PET/CT scanner.
Time frame
4 weeksSecondary outcomes
1
Dosimetry
Calculation of radiation dosimetry from FTHA for whole body and individual organs will be completed.
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov