Exploratory Study Using a New Head-only PET Scanner / ExploreNeuroLF

Brain Diseases Clinical Trial

Official title:

Exploratory Study of NeuroLF, an Investigational Medical Device Without CE Marking for PET Imaging of the Human Brain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344871
• Other study ID #: 002
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: Positrigo AG
• Contact: Jannis Fischer, Dr.
• Phone: +41445155331
• Email: jannis.fischer[@]positrigo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases

Intervention

Device:
• NeuroLF
NeuroLF Scan
• Conventional PET scan
Scan on conventional PET system

Locations

Country	Name	City	State
Germany	University Hospital Leipzig	Leipzig
Switzerland	University Hospital Zurich	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
Positrigo AG	University of Leipzig, University of Zurich

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	Ease of Placement (Usability)	100-Visual Analog Scale question how easy it was to place the patient on NeuroLF vs. the comparator	1 day
Secondary	Usage of accessories for patient placement (Usability)	Multiple Choice question which accessories were used to stabilize the patient.	1 day