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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07645573
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

  • Lymphatic Obstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • [18F]FTHA PET/CT scan — DIAGNOSTIC_TEST
    Positron Emission Tomography/Computed Tomography (PET/CT) scans

Study Details

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).

Key Dates

Start date
Oct 10, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Healthy Volunteer
    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.
  • Experimental: TD-Venous Obstruction patients
    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.

Primary Outcome Measure

FTHA transit time [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania HospitalPhiladelphiaPennsylvania19104
Erin Schubert
215-573-6569
Paco Bravo, MD (PRINCIPAL_INVESTIGATOR)
Maxim Itkin, MD (SUB_INVESTIGATOR)

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