Exploratory Study Using a New Head-only PET Scanner

NCT04511546 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Usability (patient feedback for seat comfort)

  1 day

• Usability (medical technologist feedback for ease of positioning)

  1 day

Other Outcomes (3)

• Assessment of adverse events

  During the imaging procedure which should last 15 minutes.

• Assessment of device deficiencies

  During the imaging procedure which should last 15 minutes.

• Identification of new risks

  During the imaging procedure which should last 15 minutes.

Study Arms (1)

BPET Scan

EXPERIMENTAL

Device: BPET Prototype Scan

Interventions

BPET Prototype Scan DEVICE

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

BPET Scan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Positrigo AG: lead
• University of Zurich: collaborator

Study Sites (1)

PET Center Schlieren

Schlieren, Canton of Zurich, 8952, Switzerland

Location

MeSH Terms

Conditions

Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Martin Hüllner, PD Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 13, 2020
• Study Start: October 27, 2020
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)