Exploratory Study Using a New Head-only PET Scanner

Not Applicable

Completed

• Conditions: Brain Diseases
• Interventions: Device: BPET Prototype Scan

• Registration Number: NCT04511546
• Lead Sponsor: Positrigo AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-13
• Study Start: 2020-10-27
• Status Verified: 2021-03
• Primary Completion: 2021-03-05
• Study Completion: 2021-03-05
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BPET Scan	BPET Prototype Scan	-

Primary Outcome Measures

Name	Time	Method
PET image of the brain	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.

Secondary Outcome Measures

Name	Time	Method
Usability (patient feedback for seat comfort)	1 day	The secondary outcome with respect to usability will be feedback from patients with respect to patient seat comfort.
Usability (medical technologist feedback for ease of positioning)	1 day	The secondary outcome with respect to usability will be feedback from medical technologist with respect to easiness of patient positioning.

Trial Locations

Locations (1)

PET Center Schlieren; 🇨🇭 Schlieren, ZH, Switzerland