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

Primary Purpose

Brain Diseases

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
BPET Prototype Scan
Sponsored by
Positrigo AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Brain Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • PET Center Schlieren

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BPET Scan

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Usability (patient feedback for seat comfort)
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)
The secondary outcome with respect to usability will be feedback from medical technologist with respect to easiness of patient positioning.

Full Information

First Posted
August 7, 2020
Last Updated
March 9, 2021
Sponsor
Positrigo AG
Collaborators
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04511546
Brief Title
Exploratory Study Using a New Head-only PET Scanner
Acronym
ExploreBPET
Official Title
Exploratory Study of BPET, an Investigational Medical Device Without CE-marking for PET Imaging of the Human Brain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
March 5, 2021 (Actual)
Study Completion Date
March 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Positrigo AG
Collaborators
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Diseases

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BPET Scan
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
BPET Prototype Scan
Intervention Description
Scan on the BPET Prototype PET system and qualitative comparison with a PET image acquired on a conventional clinical PET system.
Primary Outcome Measure Information:
Title
PET image of the brain
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Usability (patient feedback for seat comfort)
Description
The secondary outcome with respect to usability will be feedback from patients with respect to patient seat comfort.
Time Frame
1 day
Title
Usability (medical technologist feedback for ease of positioning)
Description
The secondary outcome with respect to usability will be feedback from medical technologist with respect to easiness of patient positioning.
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
Assessment of adverse events
Description
Safety of the procedure will be assessed by documenting adverse events (description of the adverse events, number of participants)
Time Frame
During the imaging procedure which should last 15 minutes.
Title
Assessment of device deficiencies
Description
Safety of the procedure will be assessed by documenting device deficiencies (description of the deficiency).
Time Frame
During the imaging procedure which should last 15 minutes.
Title
Identification of new risks
Description
Safety of the procedure will be assessed by identifying and documenting any new risk.
Time Frame
During the imaging procedure which should last 15 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Hüllner, PD Dr. med.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
PET Center Schlieren
City
Schlieren
State/Province
ZH
ZIP/Postal Code
8952
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Exploratory Study Using a New Head-only PET Scanner

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