University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Location contact
Erin Schubert
CONTACT
Maxim Itkin, MD
SUB_INVESTIGATOR
Paco Bravo, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07645573
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Early Phase 1
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Erin Schubert
CONTACT
Maxim Itkin, MD
SUB_INVESTIGATOR
Paco Bravo, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Positron Emission Tomography/Computed Tomography (PET/CT) scans
Time frame: 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.
Time frame: 4 weeks
Calculation of radiation dosimetry from FTHA for whole body and individual organs will be completed.
Contact information is provided by the study sponsor or research team.
Erin K Schubert, BA
CONTACT
Mary Hansbury, BS
CONTACT
University of Pennsylvania
Other
INVESTIGATION OF A POSITRON-EMITTING LONG-CHAIN FATTY ACID (18F-FTHA), FOR IMAGING OF THE INTESTINAL AND CENTRAL LYMPHATIC SYSTEM
Acronym: FTHA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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