Bacterial InfectionsPhase 1NCT04263792
[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects
A Phase 1 study testing [18F]fluoropropyl-trimethoprim in people with Bacterial Infections, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to study a radioactive tracer, a type of imaging drug that is injected into the body to see how it is taken up in sites of active infection using an imaging procedure called Positron Emission Tomography/Computed Tomography (PET/CT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- [18F]fluoropropyl-trimethoprim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2020to Sep 2027
- Phase
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Known or suspected bacterial infection, per clinical documentation of suspected infection (e.g. lab results, pathology results, physician progress notes, clinical symptoms of infection)
- Able to understand the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
Who cannot join
- Antibiotic therapy with trimethoprim within 48h of the baseline PET/CT scan
- Inability to tolerate imaging procedures, in the opinion of an investigator or treating physician
- Unstable or other severe medical or psychological comorbidities that would compromise the subject's safety or successful participation in the study, in the opinion of an investigator or treating physician
- Pregnant or breast feeding patients; a urine pregnancy test will be performed in women of child-bearing potential prior to [18F]F-TMP injection, to confirm non-pregnant status
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
Philadelphia, Pennsylvania, 19104
Erin Schubert, 215-662-3041, erinschu@pennmedicine.upenn.edu
Daniel Pryma, MD
About this study
The purpose of this study is to study a radioactive tracer, a type of imaging drug that is injected into the body to see how it is taken up in sites of active infection using an imaging procedure called Positron Emission Tomography/Computed Tomography (PET/CT).
- Conditions
- Bacterial Infections
- Being tested
- [18F]fluoropropyl-trimethoprim
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]fluoropropyl-trimethoprimDrug
[18F]Fluoropropyl-Trimethoprim, also known as [18F]F-TMP, is a radiolabeled imaging agent for positron emission tomography (PET/CT).The use most relevant to this protocol is for imaging bacterial infection in human subjects. The parent compound, trimethoprim (TMP) is a well-known, safe, broad-spectrum, synthetic, small molecule antibiotic that has been used clinically for over 50 years for the treatment of acute bacterial infection and has been combined with sulfa-based antibiotics (Bactrim/Septra) for bacterial infection prophylaxis especially in the lung and bladder. An immediate clinical use for TMP radiotracers is imaging of pathologic bacteria that are the cause of human infection.
| Study group | Role | What they receive |
|---|---|---|
| Biodistribution cohort | Other | The Biodistribution cohort will include up to 5 patients who will undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution [18F]fluoropropyl-trimethoprim PET/CT scans over a period of approximately 4 hours. Receives: Drug: [18F]fluoropropyl-trimethoprim |
| The Dynamic cohort | Other | The Dynamic cohort will include up to 15 patients who will undergo approximately 60 minutes of dynamic scanning followed by up to 2 static skull base to mid-thigh (or feet if indicated) scans post injection of [18F]fluoropropyl-trimethoprim. Receives: Drug: [18F]fluoropropyl-trimethoprim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understand the biodistribution of F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans
Understand the biodistribution of F-TMP in human patients by comparing the F-TMP uptake using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads.
Measured: 3 year
Understanding the kinetics of uptake of [18F]F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans
Understanding the the kinetics of uptake of [18F]F-TMP in human patients by comparing the F-TMP uptake using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads.
Measured: 3 years
Secondary outcomes (3)
Compare the uptake of [18F]F-TMP in infected versus non-infected tissues using PET/CT scans.
Compare the uptake of [18F]F-TMP in infected versus non-infected tissues using interpretation of PET scan images (using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads)
Measured: 3 year
Describe the change in biodistribution of uptake of [18F]F-TMP in human patients after therapy.
Describe the change in biodistribution of uptake of [18F]F-TMP in human patients after therapy using interpretation of PET scan images (using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads)
Measured: 3 year
Describe the change in kinetics of uptake of [18F]F-TMP in human patients after therapy.
Describe the change in kinetics of uptake of [18F]F-TMP in human patients after therapy (using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads)
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start7 Feb 2020
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies 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
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Pryma, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263792
- Sponsor's protocol ID
- 833998
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2020
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects
- ClinicalTrials.gov ID
- NCT04263792
- Acronym / sponsor ID
- 833998
- Conditions
- Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Feb 2020 (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 purpose of this study is to study a radioactive tracer, a type of imaging drug that is injected into the body to see how it is taken up in sites of active infection using an imaging procedure called Positron Emission Tomography/Computed Tomography (PET/CT).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodistribution cohort | Other | Drug: [18F]fluoropropyl-trimethoprimThe Biodistribution cohort will include up to 5 patients who will undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution [18F]fluoropropyl-trimethoprim PET/CT scans over a period of approximately 4 hours. |
| The Dynamic cohort | Other | Drug: [18F]fluoropropyl-trimethoprimThe Dynamic cohort will include up to 15 patients who will undergo approximately 60 minutes of dynamic scanning followed by up to 2 static skull base to mid-thigh (or feet if indicated) scans post injection of [18F]fluoropropyl-trimethoprim. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Known or suspected bacterial infection, per clinical documentation of suspected infection (e.g. lab results, pathology results, physician progress notes, clinical symptoms of infection)
- Able to understand the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
Key exclusion criteria (4 listed)
- Antibiotic therapy with trimethoprim within 48h of the baseline PET/CT scan
- Inability to tolerate imaging procedures, in the opinion of an investigator or treating physician
- Unstable or other severe medical or psychological comorbidities that would compromise the subject's safety or successful participation in the study, in the opinion of an investigator or treating physician
- Pregnant or breast feeding patients; a urine pregnancy test will be performed in women of child-bearing potential prior to [18F]F-TMP injection, to confirm non-pregnant status
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]fluoropropyl-trimethoprim[18F]Fluoropropyl-Trimethoprim, also known as [18F]F-TMP, is a radiolabeled imaging agent for positron emission tomography (PET/CT).The use most relevant to this protocol is for imaging bacterial infection in human subjects. The parent compound, trimethoprim (TMP) is a well-known, safe, broad-spectrum, synthetic, small molecule antibiotic that has been used clinically for over 50 years for the treatment of acute bacterial infection and has been combined with sulfa-based antibiotics (Bactrim/Septra) for bacterial infection prophylaxis especially in the lung and bladder. An immediate clinical use for TMP radiotracers is imaging of pathologic bacteria that are the cause of human infection. | Drug | Biodistribution cohort, The Dynamic cohort |
Primary outcome
Understand the biodistribution of F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans
Time frame: 3 year
Understand the biodistribution of F-TMP in human patients by comparing the F-TMP uptake using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads.
Understanding the kinetics of uptake of [18F]F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans
Time frame: 3 years
Understanding the the kinetics of uptake of [18F]F-TMP in human patients by comparing the F-TMP uptake using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads.
3 secondary outcomes
Compare the uptake of [18F]F-TMP in infected versus non-infected tissues using PET/CT scans.
Time frame: 3 year
Describe the change in biodistribution of uptake of [18F]F-TMP in human patients after therapy.
Time frame: 3 year
Describe the change in kinetics of uptake of [18F]F-TMP in human patients after therapy.
Time frame: 3 year
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 8 Sep 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.
Daniel Pryma, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]fluoropropyl-trimethoprim in people with Bacterial Infections, 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 3 inclusion and 4 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 8 Sep 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Schubert (215-662-3041, erinschu@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understand the biodistribution of F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans (time frame: 3 year). The study lists 2 primary outcomes in all. 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 8 Sep 2026.