NCT07645573 18F-FTHA IMAGING OF THE INTESTINAL AND CENTRAL LYMPHATIC SYSTEM

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 25 participants in total. It began in 2025-10-10 with a primary completion date of 2028-06-30.

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).

Eligibility Criteria

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.

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