25 Participants NeededMy employer runs this trial

[18F]FTHA Imaging for Lymphedema

(FTHA Trial)

EK
MH
Overseen ByMary Hansbury, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older. It includes healthy volunteers in good general health, as well as patients suspected of having a blockage in the thoracic duct (a major lymphatic vessel). Some stable chronic conditions may be allowed if they don't affect imaging.

Inclusion Criteria

I am 18 years old or older.
Healthy Volunteer Cohort: Able to provide written informed consent and participate in accordance with institutional and federal guidelines prior to study-specific procedures
I am 18 years old or older.
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Exclusion Criteria

I am currently taking medication for heart disease, high blood pressure, cholesterol, or diabetes.
I have a history of liver or kidney disease.
Healthy Volunteers and Patients: Women who are pregnant or breastfeeding; urine pregnancy test required for women of child-bearing potential on day of each PET/CT scan
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tracer Development and Testing

Development, optimization, and testing of the [18F]FTHA tracer on healthy volunteers

1 year
Multiple visits for tracer administration and imaging

Patient Imaging

Investigation of the tracer on patients with suspected obstruction of the thoracic duct

1 year
Up to 4 PET/CT scans per patient

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing a new imaging method using an injected tracer called [18F]FTHA with PET/CT scans to visualize the intestinal and central lymphatic system. First, it will be tried on healthy people, then on patients with possible lymphatic blockages.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: TD-Venous Obstruction patientsExperimental Treatment1 Intervention
Group II: Healthy VolunteerExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+