RecruitingEarly Phase 1NCT07645573

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

INVESTIGATION OF A POSITRON-EMITTING LONG-CHAIN FATTY ACID (18F-FTHA), FOR IMAGING OF THE INTESTINAL AND CENTRAL LYMPHATIC SYSTEM


Sponsor

University of Pennsylvania

Enrollment

25 participants

Start Date

Oct 10, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria12

  • 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)
  • 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.

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Interventions

DIAGNOSTIC_TEST[18F]FTHA PET/CT scan

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


Locations(1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

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NCT07645573


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