Exploratory Study Using a New Head-only PET Scanner

Brain Diseases Clinical Trial

— ExploreBPET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04511546
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: March 5, 2021

Study information

• Verified date: March 2021
• Source: Positrigo AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• 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,
• 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.

Related Conditions & MeSH terms

• Brain Diseases

Intervention

Device:
• BPET Prototype Scan
Scan on the BPET Prototype PET system and qualitative comparison with a PET image acquired on a conventional clinical PET system.

Locations

Country	Name	City	State
Switzerland	PET Center Schlieren	Schlieren	ZH

Sponsors (2)

Lead Sponsor	Collaborator
Positrigo AG	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of adverse events	Safety of the procedure will be assessed by documenting adverse events (description of the adverse events, number of participants)	During the imaging procedure which should last 15 minutes.
Other	Assessment of device deficiencies	Safety of the procedure will be assessed by documenting device deficiencies (description of the deficiency).	During the imaging procedure which should last 15 minutes.
Other	Identification of new risks	Safety of the procedure will be assessed by identifying and documenting any new risk.	During the imaging procedure which should last 15 minutes.
Primary	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	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
Secondary	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