Lymphatic Obstruction
Conditions
Keywords
thoracic duct
Brief summary
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).
Detailed description
Initially up to 10 healthy adult volunteers will be recruited for the study. All subjects will be instructed to fast overnight before the scan visit. On the study day, subjects will be fasting, and then asked to consume an Ensure drink after \[18F\]FTHA administration and before imaging begins. Tracer administration vial oral capsules and PET/CT imaging: All subjects will receive approximately 1.0 -1.5 mCi (approximately 37-55 MBq) of \[18F\]FTHA administered orally followed by dynamic imaging for up to 4 hours, with breaks between scan sessions (Figure 4) on a whole-body PET/CT system. An additional 15 patients with clinically suspected obstruction of the TD-venous junction with symptoms that may include chronic abdominal pain, edema, protein losing enteropathy and/or ascites, will be studied using the same administration and imaging procedures. Participants with disease may undergo a standard of care clinical surgical bypass procedure and be asked to return post-surgery for a follow up PET/CT imaging session.
Interventions
DIAGNOSTIC_TEST[18F]FTHA PET/CT scan
Positron Emission Tomography/Computed Tomography (PET/CT) scans
Sponsors
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria (Healthy Volunteer Cohort) 1. Male and female participants will be ≥ 18 years of age. 2. "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
Exclusion criteria
). 3. 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. Inclusion (Patient with suspected TD-venous junction obstruction cohort) 1. Male and female participants will be ≥ 18 years of age 2. 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. 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FTHA transit time | 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetry | 4 weeks | Calculation of radiation dosimetry from FTHA for whole body and individual organs will be completed. |
Countries
United States
Contacts
CONTACTErin K Schubert, BA
CONTACTMary Hansbury, BS
Outcome results
None listed