Imaging of the intestinal and central lymphatic system with 18F-FTHA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In the first year, researchers will develop and optimize the 18F-FTHA tracer and test it in healthy volunteers. In the second year, the tracer will be used in patients with suspected thoracic duct obstruction to assess its imaging performance. Participants will fast, receive the tracer orally, and undergo dynamic PET/CT imaging for up to four hours, with a follow-up imaging session after any surgical bypass procedures if performed. The study includes a healthy volunteer cohort and a patient cohort with suspected TD-venous junction obstruction, with standard-of-care follow-ups as applicable. This is an early-phase interventional study focusing on tracer feasibility and imaging characteristics.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Pennsylvania Hospital
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Erin K Schubert, BA
• Email: erin.schubert@pennmedicine.upenn.edu
• Phone: 2155736569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.