Lymphatic ObstructionEarly Phase 1FTHANCT07645573
18F-FTHA IMAGING OF THE INTESTINAL AND CENTRAL LYMPHATIC SYSTEM
A Early Phase 1 study testing [18F]FTHA PET/CT scan in people with Lymphatic Obstruction, run by University of Pennsylvania at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Obstruction
- What is being tested?
- [18F]FTHA PET/CT scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2025to 30 Jun 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants will be ≥ 18 years of age.
- "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).
- 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
Who cannot join
- 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
- Exclusion Criteria that applies to Healthy Volunteers and Patients:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Erin Schubert, 215-573-6569, erinschu@pennmedicine.upenn.edu
Paco Bravo, MD
About this study
Official title: INVESTIGATION OF A POSITRON-EMITTING LONG-CHAIN FATTY ACID (18F-FTHA), FOR IMAGING OF THE INTESTINAL AND CENTRAL LYMPHATIC SYSTEM
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).
Read the detailed description
Initially up to 10 healthy adult volunteers will be recruited for the study. All subjects will be instructed to fast overnight before the scan visit. On the study day, subjects will be fasting, and then asked to consume an Ensure drink after [18F]FTHA administration and before imaging begins. Tracer administration vial oral capsules and PET/CT imaging: All subjects will receive approximately 1.0 -1.5 mCi (approximately 37-55 MBq) of [18F]FTHA administered orally followed by dynamic imaging for up to 4 hours, with breaks between scan sessions (Figure 4) on a whole-body PET/CT system.
An additional 15 patients with clinically suspected obstruction of the TD-venous junction with symptoms that may include chronic abdominal pain, edema, protein losing enteropathy and/or ascites, will be studied using the same administration and imaging procedures.
Participants with disease may undergo a standard of care clinical surgical bypass procedure and be asked to return post-surgery for a follow up PET/CT imaging session.
- Conditions
- Lymphatic Obstruction
- Being tested
- [18F]FTHA PET/CT scan
- Keywords
- thoracic duct
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FTHA PET/CT scanDiagnostic test
Positron Emission Tomography/Computed Tomography (PET/CT) scans
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Experimental | 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. Receives: Diagnostic Test: [18F]FTHA PET/CT scan |
| TD-Venous Obstruction patients | Experimental | 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. Receives: Diagnostic Test: [18F]FTHA PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
FTHA transit time
To determine the normal [18F-]FTHA transit times through the intestinal lymphatic system, and TD among healthy human subjects imaged on a whole body PET/CT scanner.
Measured: 4 weeks
Secondary outcomes (1)
Dosimetry
Calculation of radiation dosimetry from FTHA for whole body and individual organs will be completed.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start10 Oct 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic ObstructionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paco Bravo, MD, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645573
- Sponsor's protocol ID
- 857341
- Acronym
- FTHA
- Status last verified
- Aug 2026
- First submitted
- 8 Jun 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION OF A POSITRON-EMITTING LONG-CHAIN FATTY ACID (18F-FTHA), FOR IMAGING OF THE INTESTINAL AND CENTRAL LYMPHATIC SYSTEM
- ClinicalTrials.gov ID
- NCT07645573
- Acronym / sponsor ID
- FTHA / 857341
- Conditions
- Lymphatic Obstruction
- Keywords
- thoracic duct
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Initially up to 10 healthy adult volunteers will be recruited for the study. All subjects will be instructed to fast overnight before the scan visit. On the study day, subjects will be fasting, and then asked to consume an Ensure drink after [18F]FTHA administration and before imaging begins. Tracer administration vial oral capsules and PET/CT imaging: All subjects will receive approximately 1.0 -1.5 mCi (approximately 37-55 MBq) of [18F]FTHA administered orally followed by dynamic imaging for up to 4 hours, with breaks between scan sessions (Figure 4) on a whole-body PET/CT system.
An additional 15 patients with clinically suspected obstruction of the TD-venous junction with symptoms that may include chronic abdominal pain, edema, protein losing enteropathy and/or ascites, will be studied using the same administration and imaging procedures.
Participants with disease may undergo a standard of care clinical surgical bypass procedure and be asked to return post-surgery for a follow up PET/CT imaging session.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | Experimental | Diagnostic Test: [18F]FTHA PET/CT scanHealthy 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. |
| TD-Venous Obstruction patients | Experimental | Diagnostic Test: [18F]FTHA PET/CT scanPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female participants will be ≥ 18 years of age.
- "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).
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FTHA PET/CT scanPositron Emission Tomography/Computed Tomography (PET/CT) scans | Diagnostic test | Healthy Volunteer, TD-Venous Obstruction patients |
Primary outcome
FTHA transit time
Time frame: 4 weeks
To determine the normal [18F-]FTHA transit times through the intestinal lymphatic system, and TD among healthy human subjects imaged on a whole body PET/CT scanner.
1 secondary outcome
Dosimetry
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]FTHA PET/CT scan in people with Lymphatic Obstruction, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin K Schubert, BA (2155736569, erin.schubert@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FTHA transit time (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.