HealthyPhase 1NCT02379338
Study of Radiotracer [18F]Fluortriopride ([18F]FTP) by PET/CT
A Phase 1 study testing [18F]Fluortriopride in people with Healthy, run by University of Pennsylvania at 1 site in United States.
Trial summary
In this phase 1 pilot study, positron emission tomography (PET/CT) imaging will be used to determine the biodistribution, metabolism and excretion of a novel radiotracer [18F]Fluortriopride ([18F]FTP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [18F]Fluortriopride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2015to 9 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Participants will be ≥ 18 years of age
- "Healthy volunteer" is defined as being in good general health in the opinion of an investigator (controlled diabetes, controlled hypertension or other well controlled chronic medical conditions may be allowed at the discretion of an investigator if they do not believe they will increase patient risk or interfere with the collection of imaging data, specific excluded conditions are described under exclusion criteria)
- 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.
Who cannot join
- Females who are pregnant at the time of screening will not be eligible for this study, urine or blood pregnancy test will be performed in women of child-bearing potential at screening.
- Body Mass Index (BMI) > 35
- Sustained uncontrolled hypertension (Systolic blood pressure greater than 160 mm Hg and/or diastolic blood pressure greater than 110 mm Hg) at screening intake session. If either of the pressure values is above the stated limits on the initial assessment, blood pressure may be re-tested twice after initial assessment at five minute intervals (for a total of 3 blood pressure assessments). The pressure elevation is considered sustained if either the systolic or diastolic pressure values are outside the stated limits for all three assessments, and the subject will be excluded from study participation.
- History of epilepsy or seizure disorder as assessed by medical record review and/or self-reported
- History of head trauma, that in the opinion of an investigator may interfere with the uptake of [18F]FTP as assessed by medical record review and/or self-reported
- History of Post-Traumatic Stress Disorder (PTSD), bipolar disorder, schizophrenia or psychotic disorder as assessed by medical record review and/or self-reported
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- Use of dopaminergic CNS stimulants (prescription, over-the counter or recreational drugs) within 30 days of screening intake visit , as assessed by review of health history form and concomitant medication review at screening intake visit (from medical record and/or self-reported) that are deemed by a physician investigator to have a potential influence on the binding of [18F]FTP
- Positive urine drug screen at the screening intake visit
- Self-reported current alcohol consumption that exceeds greater than 25 drinks per week
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19107
About this study
Official title: Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluotriopride ([18F]FTP) by PET/CT
In this phase 1 pilot study, positron emission tomography (PET/CT) imaging will be used to determine the biodistribution, metabolism and excretion of a novel radiotracer [18F]Fluortriopride ([18F]FTP).
Read the detailed description
[18F]FTP is a novel radioactive tracer that has shown potential in labeling dopamine D3 receptors through PET/CT imaging. This is a phase 1 study design meant to evaluate safety, biodistribution and brain uptake of [18F]FTP in healthy volunteers.
- Conditions
- Healthy
- Being tested
- [18F]Fluortriopride
- Keywords
- Dopamine D3 receptor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FluortrioprideDrug
Also called [18F]FTP
All subjects will receive a [18F]Fluortriopride PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Brain Cohort | Experimental | The Dynamic Brain cohort will include up to 10 patients who will undergo a dynamic brain [18F]Fluortriopride PET/CT scan over a period of approximately 2 hours. Subjects in this cohort will also undergo a research brain MRI, generally on a separate day from the PET/CT. Receives: Drug: [18F]Fluortriopride |
| Biodistribution Cohort | Experimental | The Biodistribution cohort will include up to10 patients who will undergo a series of whole body biodistribution [18F]Fluortriopride PET/CT scans over a period of approximately 4 hours. Receives: Drug: [18F]Fluortriopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine biodistribution of the radioactive investigational drug ([18F]fluortriopride) in healthy volunteers and calculate human dosimetry.
Assessing the biodistribution of the radioactive investigational drug ([18F]fluortriopride) and calculation of human dosimetry in healthy volunteers are completed with MRI results from Dynamic Brain cohort, PET/CT results and laboratory results.
Measured: 1 week
Demonstrate the feasibility of imaging the brain with the dopamine D3 receptor imaging agent [18F]fluortriopride
Participants will complete an anatomical MRI scan on an MRI scanner (without contrast) to enable precise anatomic location of the PET scan results. MRI and PET images will be co-registered so that the anatomical structures observed on the MRI can be accurately outlined on the PET scans for analysis.
Measured: 1 week
Secondary outcomes (1)
Evaluate the safety of [18F]fluortriopride
Safety of the radioactive investigational drug ([18F]fluortriopride) as measured by the number of participants with adverse events and significant changes in laboratory and/or PET/CT results.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start27 Mar 2015
- Primary completion9 Jun 2026
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Dubroff, MD, PhD, Principal investigator, Hospital of University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379338
- Sponsor's protocol ID
- 820959
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2015
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Mach RH, Tu Z, Xu J, Li S, Jones LA, Taylor M, Luedtke RR, Derdeyn CP, Perlmutter JS, Mintun MA. Endogenous dopamine (DA) competes with the binding of a radiolabeled D(3) receptor partial agonist in vivo: a positron emission tomography study. Synapse. 2011 Aug;65(8):724-32. doi: 10.1002/syn.20891. Epub 2011 Mar 21.
PubMed 21132811
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluotriopride ([18F]FTP) by PET/CT
- ClinicalTrials.gov ID
- NCT02379338
- Acronym / sponsor ID
- 820959
- Conditions
- Healthy
- Keywords
- Dopamine D3 receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 27 Mar 2015 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 4 Mar 2015 (estimated)
- 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.
In this phase 1 pilot study, positron emission tomography (PET/CT) imaging will be used to determine the biodistribution, metabolism and excretion of a novel radiotracer [18F]Fluortriopride ([18F]FTP).
Detailed description
[18F]FTP is a novel radioactive tracer that has shown potential in labeling dopamine D3 receptors through PET/CT imaging. This is a phase 1 study design meant to evaluate safety, biodistribution and brain uptake of [18F]FTP in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic Brain Cohort | Experimental | Drug: [18F]FluortrioprideThe Dynamic Brain cohort will include up to 10 patients who will undergo a dynamic brain [18F]Fluortriopride PET/CT scan over a period of approximately 2 hours. Subjects in this cohort will also undergo a research brain MRI, generally on a separate day from the PET/CT. |
| Biodistribution Cohort | Experimental | Drug: [18F]FluortrioprideThe Biodistribution cohort will include up to10 patients who will undergo a series of whole body biodistribution [18F]Fluortriopride PET/CT scans over a period of approximately 4 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants will be ≥ 18 years of age
- "Healthy volunteer" is defined as being in good general health in the opinion of an investigator (controlled diabetes, controlled hypertension or other well controlled chronic medical conditions may be allowed at the discretion of an investigator if they do not believe they will increase patient risk or interfere with the collection of imaging data, specific excluded conditions are described under exclusion criteria)
- 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.
Key exclusion criteria (11 listed)
- Females who are pregnant at the time of screening will not be eligible for this study, urine or blood pregnancy test will be performed in women of child-bearing potential at screening.
- Body Mass Index (BMI) > 35
- Sustained uncontrolled hypertension (Systolic blood pressure greater than 160 mm Hg and/or diastolic blood pressure greater than 110 mm Hg) at screening intake session. If either of the pressure values is above the stated limits on the initial assessment, blood pressure may be re-tested twice after initial assessment at five minute intervals (for a total of 3 blood pressure assessments). The pressure elevation is considered sustained if either the systolic or diastolic pressure values are outside the stated limits for all three assessments, and the subject will be excluded from study participation.
- History of epilepsy or seizure disorder as assessed by medical record review and/or self-reported
- History of head trauma, that in the opinion of an investigator may interfere with the uptake of [18F]FTP as assessed by medical record review and/or self-reported
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]FluortrioprideAlso: [18F]FTPAll subjects will receive a [18F]Fluortriopride PET/CT scan | Drug | Biodistribution Cohort, Dynamic Brain Cohort |
Primary outcome
Determine biodistribution of the radioactive investigational drug ([18F]fluortriopride) in healthy volunteers and calculate human dosimetry.
Time frame: 1 week
Assessing the biodistribution of the radioactive investigational drug ([18F]fluortriopride) and calculation of human dosimetry in healthy volunteers are completed with MRI results from Dynamic Brain cohort, PET/CT results and laboratory results.
Demonstrate the feasibility of imaging the brain with the dopamine D3 receptor imaging agent [18F]fluortriopride
Time frame: 1 week
Participants will complete an anatomical MRI scan on an MRI scanner (without contrast) to enable precise anatomic location of the PET scan results. MRI and PET images will be co-registered so that the anatomical structures observed on the MRI can be accurately outlined on the PET scans for analysis.
1 secondary outcome
Evaluate the safety of [18F]fluortriopride
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 21132811Mach RH, Tu Z, Xu J, Li S, Jones LA, Taylor M, Luedtke RR, Derdeyn CP, Perlmutter JS, Mintun MA. Endogenous dopamine (DA) competes with the binding of a radiolabeled D(3) receptor partial agonist in vivo: a positron emission tomography study. Synapse. 2011 Aug;65(8):724-32. doi: 10.1002/syn.20891. Epub 2011 Mar 21.
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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. This study is not recruiting at the moment.
Jacob Dubroff, MD, PhD principal investigator
Hospital of 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]Fluortriopride in people with Healthy, 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 11 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: finished, as of the sponsor's last update on 17 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine biodistribution of the radioactive investigational drug ([18F]fluortriopride) in healthy volunteers and calculate human dosimetry. (time frame: 1 week). 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?
On the ClinicalTrials.gov record for NCT02379338, which also lists 1 linked publication.
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 17 Jun 2026.