18F-FTHA IMAGING OF THE INTESTINAL AND CENTRAL LYMPHATIC SYSTEM

NCT07645573 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 857341
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

thoracic duct

Outcome Measures

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.

  4 weeks

Secondary Outcomes (1)

• Dosimetry

  4 weeks

Study Arms (2)

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.

Diagnostic Test: [18F]FTHA PET/CT scan

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.

Diagnostic Test: [18F]FTHA PET/CT scan

Interventions

[18F]FTHA PET/CT scan DIAGNOSTIC_TEST

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

Healthy Volunteer; TD-Venous Obstruction patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants will be ≥ 18 years of age.

You may not qualify if:

• 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
• 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
• Known history of liver or kidney disease per medical record review and/or self-report
• 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.
• Subjects who report claustrophobia or Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
• Self-reported difficulty with swallowing pills or allergy to components of Ensure Plus
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Central Study Contacts

Erin K Schubert, BA

CONTACT

2155736569; erin.schubert@pennmedicine.upenn.edu

Mary Hansbury, BS

CONTACT

215-746-8192; mary.hansbury@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: October 10, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)