Exploratory Study Using a New Head-only PET Scanner (ExploreBPET)

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Diseases
• Intervention / Treatment: Device: BPET Prototype Scan

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Schlieren, ZH, Switzerland, 8952
      • PET Center Schlieren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BPET Scan	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Positrigo AG
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Martin Hüllner, PD Dr. med., University of Zurich

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 27, 2020
• Primary Completion (ACTUAL): March 5, 2021
• Study Completion (ACTUAL): March 5, 2021

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (ACTUAL): August 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Brain Diseases
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No