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Completed

NCT Number: NCT04511546

Exploratory Study Using a New Head-only PET Scanner

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.

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Key information

Conditions

Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PET Center Schlieren

Schlieren, Canton of Zurich, 8952, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. PET image of the brain

    Time frame: 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 outcomes

  1. Usability (patient feedback for seat comfort)

    Time frame: 1 day

    The secondary outcome with respect to usability will be feedback from patients with respect to patient seat comfort.

  2. Usability (medical technologist feedback for ease of positioning)

    Time frame: 1 day

    The secondary outcome with respect to usability will be feedback from medical technologist with respect to easiness of patient positioning.

Other outcomes

  1. Assessment of adverse events

    Time frame: During the imaging procedure which should last 15 minutes.

    Safety of the procedure will be assessed by documenting adverse events (description of the adverse events, number of participants)

  2. Assessment of device deficiencies

    Time frame: During the imaging procedure which should last 15 minutes.

    Safety of the procedure will be assessed by documenting device deficiencies (description of the deficiency).

  3. Identification of new risks

    Time frame: During the imaging procedure which should last 15 minutes.

    Safety of the procedure will be assessed by identifying and documenting any new risk.

Sponsors and collaborators

Lead sponsor

Positrigo AG

Industry

Collaborators

  • University of Zurich

Registry information

Official study title

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

Acronym: ExploreBPET

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2020
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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