11C-Trimethoprim PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | February 1, 2018 |
| End Date: | November 2019 |
| Contact: | Jenny Cai, BS |
| Email: | jenny.cai@uphs.upenn.edu |
| Phone: | 215-898-4346 |
11C-Trimethoprim PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human
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.
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.
Inclusion Criteria:
1. Inclusion Criteria at least 18 years of age
2. Known or suspected bacterial infection.
3. Participants must be informed of the investigational nature of this study and provide
written informed consent in accordance with institutional and federal guidelines prior
to study-specific procedures.
Exclusion Criteria:
1. Antibiotic therapy with trimethoprim within 48h of the baseline PET/CT scan.
2. Inability to tolerate imaging procedures in the opinion of an investigator or treating
physician
3. Serious or unstable medical or psychological comorbidities that, in the opinion of the
investigator, would compromise the subject's safety or successful participation in the
study.
4. Females who are pregnant or breast feeding at the time of screening will not be
eligible for this study; a urine pregnancy test will be performed in women of
child-bearing potential at screening.
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Phone: 215-898-4346
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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