Brain Diseases
Conditions
Brief 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. 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.
Interventions
DEVICENeuroLF
NeuroLF Scan
DEVICEConventional PET scan
Scan on conventional PET system
Sponsors
University of Zurich
University of Leipzig
Positrigo AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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, * Pregnant or Breastfeeding women, * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET Image of the Brain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Placement (Usability) | 1 day | 100-Visual Analog Scale question how easy it was to place the patient on NeuroLF vs. the comparator |
| Usage of accessories for patient placement (Usability) | 1 day | Multiple Choice question which accessories were used to stabilize the patient. |
Countries
Germany, Switzerland
Contacts
Primary ContactJannis Fischer, Dr.
Backup ContactDiego Stohrer, MSc.
Outcome results
None listed