Brain DiseasesNCT06344871
Exploratory Study Using a New Head-only PET Scanner / ExploreNeuroLF
A study testing NeuroLF and Conventional PET scan in people with Brain Diseases, run by Positrigo AG at 2 sites in 2 countries.
Trial summary
The "NeuroLF prototype" is a small aperture PET scanner. The NeuroLF prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Diseases
- What is being tested?
- NeuroLF and Conventional PET scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Mar 2024to 6 Aug 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Capable of giving Informed Consent as documented by signature (Appendix Informed Consent Form).
- Ability to sit still in the head-only PET scanner for 15 minutes.
- Are scheduled to receive a regular brain PET scan as part of clinical routine.
- Male and Female patients 18 years to 80 years of age.
Who cannot join
- Contraindications to PET examination,
- Patient height smaller than 160 cm or taller than 200 cm,
- Patient weight more than 120 kg,
- Patient cannot sit upright for at least 15 minutes,
- Metal implants in the head,
- Pregnant or Breastfeeding women,
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- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug/device within the 30 days preceding and during the present study,
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Exploratory Study of NeuroLF, an Investigational Medical Device Without CE Marking for PET Imaging of the Human Brain
The "NeuroLF prototype" is a small aperture PET scanner. The NeuroLF prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the NeuroLF prototype without the need for an additional radioactive tracer dose.
The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the NeuroLF prototype.
- Conditions
- Brain Diseases
- Being tested
- NeuroLF, Conventional PET scan
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroLFDevice
NeuroLF Scan
Conventional PET scanDevice
Scan on conventional PET system
| Study group | Role | What they receive |
|---|---|---|
| NeuroLF Scan | Experimental | Scan on the NeuroLF PET system. Receives: Device: NeuroLF |
| Comparator Scan | Active comparator | Scan on a conventional clinical PET system. Receives: Device: Conventional PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET Image of the Brain
The primary outcome will be a PET image of the brain for each participant taken on NeuroLF. It will be compared against the image taken by the conventional PET machine by a trained physician and judged by whether it could be used for diagnosis and further analysis.
Measured: 1 day
Secondary outcomes (2)
Ease of Placement (Usability)
100-Visual Analog Scale question how easy it was to place the patient on NeuroLF vs. the comparator
Measured: 1 day
Usage of accessories for patient placement (Usability)
Multiple Choice question which accessories were used to stabilize the patient.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start13 Mar 2024
- Primary completion6 Aug 2026
- Study completion6 Aug 2026
Why it stopped: Clinical data complete for regulatory clearances
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Positrigo AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Zurich, University of Leipzig
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344871
- Sponsor's protocol ID
- 002
- Status last verified
- May 2025
- First submitted
- 21 Mar 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of NeuroLF, an Investigational Medical Device Without CE Marking for PET Imaging of the Human Brain
- ClinicalTrials.gov ID
- NCT06344871
- Acronym / sponsor ID
- 002
- Conditions
- Brain Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinical data complete for regulatory clearances
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Positrigo AGIndustry (pharma, biotech, devices)
- Collaborators
- University of Zurich, University of Leipzig
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 6 Aug 2026 (actual)
- First posted
- 3 Apr 2024 (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 "NeuroLF prototype" is a small aperture PET scanner. The NeuroLF prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the NeuroLF prototype without the need for an additional radioactive tracer dose.
The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the NeuroLF prototype.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroLF Scan | Experimental | Device: NeuroLFScan on the NeuroLF PET system. |
| Comparator Scan | Active comparator | Device: Conventional PET scanScan on a conventional clinical PET system. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Capable of giving Informed Consent as documented by signature (Appendix Informed Consent Form).
- Ability to sit still in the head-only PET scanner for 15 minutes.
- Are scheduled to receive a regular brain PET scan as part of clinical routine.
- Male and Female patients 18 years to 80 years of age.
Key exclusion criteria (11 listed)
- Contraindications to PET examination,
- Patient height smaller than 160 cm or taller than 200 cm,
- Patient weight more than 120 kg,
- Patient cannot sit upright for at least 15 minutes,
- Metal implants in the head,
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 |
|---|---|---|
| NeuroLFNeuroLF Scan | Device | NeuroLF Scan |
| Conventional PET scanScan on conventional PET system | Device | Comparator Scan |
Primary outcome
PET Image of the Brain
Time frame: 1 day
The primary outcome will be a PET image of the brain for each participant taken on NeuroLF. It will be compared against the image taken by the conventional PET machine by a trained physician and judged by whether it could be used for diagnosis and further analysis.
2 secondary outcomes
Ease of Placement (Usability)
Time frame: 1 day
Usage of accessories for patient placement (Usability)
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Clinical data complete for regulatory clearances). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroLF and Conventional PET scan in people with Brain Diseases, run by Positrigo AG at 2 sites in 2 countries.
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 4 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: stopped early, as of the sponsor's last update on 18 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 2 sites in Germany, Switzerland. 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.
Are results available for this study?
The study was stopped early (reason given: Clinical data complete for regulatory clearances). Results are not available in the source record.
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?
PET Image of the Brain (time frame: 1 day). 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 18 Sep 2026.