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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteer | Experimental | 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. |
|
| TD-Venous Obstruction patients | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]FTHA PET/CT scan | Diagnostic Test | Positron Emission Tomography/Computed Tomography (PET/CT) scans |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dosimetry | Calculation of radiation dosimetry from FTHA for whole body and individual organs will be completed. | 4 weeks |
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Inclusion Criteria:
Inclusion Criteria (Healthy Volunteer Cohort)
Inclusion (Patient with suspected TD-venous junction obstruction cohort)
Exclusion Criteria:
Exclusion Criteria that apply to Healthy Volunteers only
Exclusion Criteria that applies to Healthy Volunteers and Patients:
Participant may not be involved in any other research studies involving ionizing radiation conducted within 1 year of their participation of this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin K Schubert, BA | Contact | 2155736569 | erin.schubert@pennmedicine.upenn.edu | |
| Mary Hansbury, BS | Contact | 215-746-8192 | mary.hansbury@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Hospital | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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