Heathy VolunteerPhase 2NCT07542158
Ultralow Dose PET Imaging of 18F-FDOPA
A Phase 2 study testing 18F-FDOPA in people with Heathy Volunteer and Parkinsonian Syndromes, run by Akiva Mintz at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for Parkinsonian syndromes, neuroendocrine tumors, and gliomas detection and monitoring. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Heathy Volunteer, Parkinsonian Syndromes, Neuroendocrine (NE) Tumors
- What is being tested?
- 18F-FDOPA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 30 Jun 2030
- Phase
- Phase 2
- 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 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥18 years.
- ability to provide informed consent and comply with study procedures.
- for female participants:
- must not be pregnant or breastfeeding.
- negative pregnancy test required for women of childbearing potential.
Who cannot join
- participants who have exceeded Nuclear Regulatory Commission regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total).
- more than four prior enrollments in this study.
- participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the pet scan
- medication \& prior treatment exclusions
- concurrent treatments that may interfere with radiotracer uptake as determined by the Principal Investigator.
- pregnant or breastfeeding individuals (negative pregnancy test required)
- inability to provide informed consent
- any condition that, in the investigator's judgment, may compromise participant safety or study integrity.
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
Nuclear Imaging Institute
Englewood, New Jersey, 07631
About this study
Official title: Evaluation of Ultralow Dose PET Imaging for Detecting 18F-FDOPA Uptake
The goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for Parkinsonian syndromes, neuroendocrine tumors, and gliomas detection and monitoring. The main question it aims to answer is:
Can the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard? Participants will be injected with a radioactive tracer called 18F-FDOPA and be imaged on a new type of high sensitivity PET scanner for up to 3 hours.
Read the detailed description
This research study aims to evaluate an investigational ultralow dose PET imaging technique for Parkinsonian syndromes, neuroendocrine tumors, and gliomas detection and monitoring. "Investigational" means that the procedure or drug being studied is not yet approved by the FDA for the specific use being tested in this research. The PET imaging technique used in this study is considered investigational because it is being tested at an ultralow radiation dose that has not yet been approved for clinical use. The radiotracer, 18F-FDOPA, is FDA-approved for detecting prostate cancer at standard doses.
18F-FDOPA is often found to be taken up at higher levels in Parkinsonian syndromes, neuroendocrine tumors, and gliomas. In this study, investigators will use a very small amount of this tracer (less than 1/20th of the standard dose) along with advanced PET imaging technology to see if it is possible to create clear images while using much less radiation. This study aims to develop a safer imaging technique that could potentially be used more frequently for screening and monitoring Parkinsonian syndromes, neuroendocrine tumors, and gliomas.
Investigators will enroll individuals with and without Parkinsonian syndromes, neuroendocrine tumors, and gliomas to evaluate how ultralow dose PET imaging detects 18F-FDOPA uptake in different type of tissue.
Approximately 200 people will be enrolled in this study at the Nuclear Imaging Institute.
- Being tested
- 18F-FDOPA
- Medical subject headings
- Parkinsonian Disorders, Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDOPADrug
Also called CT scan, PET scan, blood collection
Participants will be injected with 18F-FDOPA and imaged for up to 3 hours on a PET scanner
| Study group | Role | What they receive |
|---|---|---|
| ultralow dose 18F-FDOPA imaging group | Other | Participants will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours Receives: Drug: 18F-FDOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal-to-Noise Ratio (SNR)
Measurement of signal-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions.
Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up).
Unit of Measure: SNR (unitless, numeric ratio)
Measured: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Contrast-to-Noise Ratio (CNR)
Measurement of contrast-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions.
Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up).
Unit of Measure: CNR (unitless, numeric ratio)
Measured: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Coefficient of Variation (COV)
Measurement of the coefficient of variation in selected regions for evaluating image consistency across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions.
Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up).
Unit of Measure: Percentage (%)
Measured: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Spatial Resolution (Full Width at Half Maximum - FWHM)
Assessment of spatial resolution using full width at half maximum (FWHM) across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions.
Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up).
Unit of Measure: Millimeters (mm)
Measured: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Target-to-Background Ratio (TBR)
Assessment of target-to-background ratio for evaluating PSMA-expressing tissue contrast across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions.
Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up).
Unit of Measure: Ratio (unitless numeric ratio)
Measured: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Qualitative Image Quality Score (Likert Scale)
Independent qualitative evaluation of overall image quality, lesion detectability, image noise, and artifacts by nuclear medicine physicians, assessed using a 5-point Likert scale.
Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up).
Unit of Measure: Score on Likert Scale (1-5; 1 = worst, 5 = best)
Measured: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Inter-reader Agreement (Weighted Kappa Statistics)
Measurement of agreement among readers evaluating qualitative image quality scores, analyzed using weighted kappa statistics.
Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up).
Unit of Measure: Weighted kappa statistic (numeric value ranging from 0 to 1, 0 = no agreement, 1 = perfect agreement)
Measured: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start12 May 2025
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathy VolunteerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akiva Mintz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Akiva Mintz, Nuclear Imaging Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542158
- Sponsor's protocol ID
- NII-0004-FDOPA
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultralow Dose PET Imaging for Detecting 18F-FDOPA Uptake
- ClinicalTrials.gov ID
- NCT07542158
- Acronym / sponsor ID
- NII-0004-FDOPA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Akiva MintzUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 21 Apr 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 goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for Parkinsonian syndromes, neuroendocrine tumors, and gliomas detection and monitoring. The main question it aims to answer is:
Can the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard? Participants will be injected with a radioactive tracer called 18F-FDOPA and be imaged on a new type of high sensitivity PET scanner for up to 3 hours.
Detailed description
This research study aims to evaluate an investigational ultralow dose PET imaging technique for Parkinsonian syndromes, neuroendocrine tumors, and gliomas detection and monitoring. "Investigational" means that the procedure or drug being studied is not yet approved by the FDA for the specific use being tested in this research. The PET imaging technique used in this study is considered investigational because it is being tested at an ultralow radiation dose that has not yet been approved for clinical use. The radiotracer, 18F-FDOPA, is FDA-approved for detecting prostate cancer at standard doses.
18F-FDOPA is often found to be taken up at higher levels in Parkinsonian syndromes, neuroendocrine tumors, and gliomas. In this study, investigators will use a very small amount of this tracer (less than 1/20th of the standard dose) along with advanced PET imaging technology to see if it is possible to create clear images while using much less radiation. This study aims to develop a safer imaging technique that could potentially be used more frequently for screening and monitoring Parkinsonian syndromes, neuroendocrine tumors, and gliomas.
Investigators will enroll individuals with and without Parkinsonian syndromes, neuroendocrine tumors, and gliomas to evaluate how ultralow dose PET imaging detects 18F-FDOPA uptake in different type of tissue.
Approximately 200 people will be enrolled in this study at the Nuclear Imaging Institute.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultralow dose 18F-FDOPA imaging group | Other | Drug: 18F-FDOPAParticipants will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥18 years.
- ability to provide informed consent and comply with study procedures.
- for female participants:
Key exclusion criteria (8 listed)
- participants who have exceeded Nuclear Regulatory Commission regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total).
- more than four prior enrollments in this study.
- participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the pet scan
- medication \& prior treatment exclusions
- pregnant or breastfeeding individuals (negative pregnancy test required)
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-FDOPAAlso: CT scan, PET scan, blood collectionParticipants will be injected with 18F-FDOPA and imaged for up to 3 hours on a PET scanner | Drug | ultralow dose 18F-FDOPA imaging group |
Primary outcome
Signal-to-Noise Ratio (SNR)
Time frame: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Measurement of signal-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: SNR (unitless, numeric ratio)
Contrast-to-Noise Ratio (CNR)
Time frame: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Measurement of contrast-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: CNR (unitless, numeric ratio)
Coefficient of Variation (COV)
Time frame: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Measurement of the coefficient of variation in selected regions for evaluating image consistency across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Percentage (%)
Spatial Resolution (Full Width at Half Maximum - FWHM)
Time frame: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Assessment of spatial resolution using full width at half maximum (FWHM) across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Millimeters (mm)
Target-to-Background Ratio (TBR)
Time frame: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Assessment of target-to-background ratio for evaluating PSMA-expressing tissue contrast across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Ratio (unitless numeric ratio)
Qualitative Image Quality Score (Likert Scale)
Time frame: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Independent qualitative evaluation of overall image quality, lesion detectability, image noise, and artifacts by nuclear medicine physicians, assessed using a 5-point Likert scale. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Score on Likert Scale (1-5; 1 = worst, 5 = best)
Inter-reader Agreement (Weighted Kappa Statistics)
Time frame: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
Measurement of agreement among readers evaluating qualitative image quality scores, analyzed using weighted kappa statistics. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Weighted kappa statistic (numeric value ranging from 0 to 1, 0 = no agreement, 1 = perfect agreement)
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 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-FDOPA in people with Heathy Volunteer and Parkinsonian Syndromes, run by Akiva Mintz 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 5 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: enrolling by invitation, as of the sponsor's last update on 21 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Signal-to-Noise Ratio (SNR) (time frame: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).). The study lists 7 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 21 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.