Brain DiseasesExploreBPETNCT04511546
Exploratory Study Using a New Head-only PET Scanner
A study testing BPET Prototype Scan in people with Brain Diseases, run by Positrigo AG at 1 site in Switzerland.
Trial summary
The "BPET prototype" is a small aperture PET scanner. The BPET 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 years
- Conditions the study is for
- Brain Diseases
- What is being tested?
- BPET Prototype Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Oct 2020to 5 Mar 2021
- 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
- No healthy volunteers
- 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,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, severe dementia, etc. of the participant,
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- 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
1 site in 1 country.
About this study
Official title: Exploratory Study of BPET, an Investigational Medical Device Without CE-marking for PET Imaging of the Human Brain
The "BPET prototype" is a small aperture PET scanner. The BPET 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 BPET 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 BPET prototype.
- Conditions
- Brain Diseases
- Being tested
- BPET Prototype 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.
BPET Prototype ScanDevice
Scan on the BPET Prototype PET system and qualitative comparison with a PET image acquired on a conventional clinical PET system.
| Study group | Role | What they receive |
|---|---|---|
| BPET Scan | Experimental | Not described Receives: Device: BPET Prototype 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 BPET. 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)
Usability (patient feedback for seat comfort)
The secondary outcome with respect to usability will be feedback from patients with respect to patient seat comfort.
Measured: 1 day
Usability (medical technologist feedback for ease of positioning)
The secondary outcome with respect to usability will be feedback from medical technologist with respect to easiness of patient positioning.
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 posted13 Aug 2020
- Study start27 Oct 2020
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Positrigo AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Martin Hüllner, PD Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511546
- Sponsor's protocol ID
- 001
- Acronym
- ExploreBPET
- Status last verified
- Mar 2021
- First submitted
- 7 Aug 2020
- Last updated
- 10 Mar 2021
- 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of BPET, an Investigational Medical Device Without CE-marking for PET Imaging of the Human Brain
- ClinicalTrials.gov ID
- NCT04511546
- Acronym / sponsor ID
- ExploreBPET / 001
- Conditions
- Brain Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Positrigo AGIndustry (pharma, biotech, devices)
- Collaborators
- University of Zurich
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 13 Aug 2020 (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 "BPET prototype" is a small aperture PET scanner. The BPET 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 BPET 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 BPET prototype.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BPET Scan | Experimental | Device: BPET Prototype Scan |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not 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 (9 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 |
|---|---|---|
| BPET Prototype ScanScan on the BPET Prototype PET system and qualitative comparison with a PET image acquired on a conventional clinical PET system. | Device | BPET 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 BPET. 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
Usability (patient feedback for seat comfort)
Time frame: 1 day
Usability (medical technologist feedback for ease of positioning)
Time frame: 1 day
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 10 Mar 2021.
- 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.
Martin Hüllner, PD Dr. med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPET Prototype Scan in people with Brain Diseases, run by Positrigo AG at 1 site in Switzerland.
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 9 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 10 Mar 2021. 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 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 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?
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 10 Mar 2021.