Recruiting
Early Phase 1

[18F]FTHA

Sponsor:

University of Pennsylvania

Code:

NCT07645573

Conditions

Lymphatic Obstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

[18F]FTHA PET/CT scan

Study Details

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).

Conditions

Lymphatic Obstruction

Study ID

NCT07645573

Start date

Oct 10, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Exclusion Criteria:

Exclusion Criteria that apply to Healthy Volunteers only

1. Currently taking medication for cardiac disease, hypertension, hyperlipidemia, diabetes mellitus, heart failure, coronary artery disease, and/or history of cardiac surgery per medical record review and/or self-report
2. Known history of liver or kidney disease per medical record review and/or self-report

Exclusion Criteria that applies to Healthy Volunteers and Patients:

1. Women who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential on the day of each of the PET/CT scans.
2. Subjects who report claustrophobia or Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
3. Self-reported difficulty with swallowing pills or allergy to components of Ensure Plus
4. Patients with a history of medical illness or disorder that in the opinion of an investigator and/or study physician could compromise patient safety or interfere with the collection of imaging data, or ability to complete the study and procedures, will be excluded.

Participant may not be involved in any other research studies involving ionizing radiation conducted within 1 year of their participation of this study.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Healthy Volunteer

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.

experimental: TD-Venous Obstruction patients

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.

Interventions

[18F]FTHA PET/CT scan

Positron Emission Tomography/Computed Tomography (PET/CT) scans

Primary outcome measure

  • FTHA transit time [ Time Frame: 4 weeks ]

Central Contacts and Locations

Locations

University of Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Paco Bravo, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • thoracic duct

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-08-06.