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Patients with suspected bacterial infection at the time screening are eligible for this study. Patients may participate in this study if they are at least 18 years of age, and most participants will be receiving care at the clinical practices of the University of Pennsylvania. Up to 30 subjects will participate in two different imaging cohorts.
The Biodistribution cohort will include up to 5 patients referred from orthopedics who will undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution [11C]trimethoprim PET/CT scans over a period of approximately 2 ½ hours.
The Dynamic cohort will include up to 25 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 imaging post injection of [11C]trimethoprim. Some subjects who may be selected clinically to undergo surgical or antibiotic treatment may undergo a second therapy may also undergo an optional second [11C]trimethoprim PET/CT after the initiation of therapy to collect pilot data on the changes in [11C]trimethoprim biodistribution and uptake with therapy, the timing of this scan may vary depending on the type of treatment the patient is receiving.
Patients will also undergo baseline lab tests complete blood count (CBC), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and blood cultures. If these tests are done as part of clinical standard of care they will not need to be repeated for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biodistribution | Experimental | The Biodistribution cohort referred from orthopedics who will undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution [11C]trimethoprim PET/CT scans over a period of approximately 2 ½ hours. |
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| Dynamic | Experimental | The Dynamic cohort will undergo approximately 60 minutes of dynamic scanning followed by up to 2 static skull base to mid-thigh (or feet if indicated) scans imaging post injection of [11C]trimethoprim. Some subjects who may be selected clinically to undergo surgical or antibiotic treatment may undergo a second therapy may also undergo an optional second [11C]trimethoprim PET/CT after the initiation of therapy to collect pilot data on the changes in [11C]trimethoprim biodistribution and uptake with therapy, the timing of this scan may vary depending on the type of treatment the patient is receiving. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-Trimethoprim | Drug | [11C]TMP is a radiolabeled imaging agent for positron emission tomography (PET/CT). Most relevant to this protocol, it is for imaging bacterial infection in human subjects. TMP is 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetics of uptake of [11C]TMP in human patients | The biodistribution which includes kinetics of uptake of [11C]TMP in human patients via PET/CT will be measured | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| [11C]trimethoprim in infected versus non-infected tissues | Measure uptake of [11C]trimethoprim in infected versus non-infected tissues via PET/CT | 3 years |
| The change in biodistribution which includes kinetics of uptake of [11C]TMP in human patients after therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Mankoff, MD PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41275068 | Derived | Young AJ, Doot RK, Cho JK, Pham JM, Ordonez AA, Del Castillo AF, Dominguez TL, Dugyala S, Schubert EK, Lee H, Pantel AR, Mach RH, Mankoff DA, Sellmyer MA. First-in-Human Biodistribution and Dosimetry of [11C]Trimethoprim. Mol Imaging Biol. 2026 Feb;28(1):60-67. doi: 10.1007/s11307-025-02064-7. Epub 2025 Nov 22. | |
| 36106638 | Derived |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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|
Describe the change in biodistribution which incldues kinetics of uptake of [11C]TMP in human via PET/CT |
| 3 years |
| Lee IK, Jacome DA, Cho JK, Tu V, Young AJ, Dominguez T, Northrup JD, Etersque JM, Lee HS, Ruff A, Aklilu O, Bittinger K, Glaser LJ, Dorgan D, Hadjiliadis D, Kohli RM, Mach RH, Mankoff DA, Doot RK, Sellmyer MA. Imaging sensitive and drug-resistant bacterial infection with [11C]-trimethoprim. J Clin Invest. 2022 Sep 15;132(18):e156679. doi: 10.1172/JCI156679. |