Exploratory Study Using a New Head-only PET Scanner

Study Overview
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Brief Summary
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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.

Official Title
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Exploratory Study of BPET, an Investigational Medical Device Without CE-marking for PET Imaging of the Human Brain

Conditions
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Brain Diseases

Intervention / Treatment
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* Device: BPET Prototype Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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, 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPET Scan<br> | Device: BPET Prototype Scan<br>* Scan on the BPET Prototype PET system and qualitative comparison with a PET image acquired on a conventional clinical PET system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability (patient feedback for seat comfort) | The secondary outcome with respect to usability will be feedback from patients with respect to patient seat comfort. | 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. | 1 day |