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NCT Number: NCT06344871

Exploratory Study Using a New Head-only PET Scanner / ExploreNeuroLF

The "NeuroLF prototype" is a small aperture PET scanner. The NeuroLF 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 NeuroLF 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 NeuroLF prototype.

Recruiting

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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

University Hospital Leipzig, Leipzig, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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,
  • Pregnant or Breastfeeding women,
  • Known or suspected non-compliance, drug or alcohol abuse,
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, 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

NeuroLF

Device

NeuroLF Scan

Conventional PET scan

Device

Scan on conventional 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 NeuroLF. 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. Ease of Placement (Usability)

    Time frame: 1 day

    100-Visual Analog Scale question how easy it was to place the patient on NeuroLF vs. the comparator

  2. Usage of accessories for patient placement (Usability)

    Time frame: 1 day

    Multiple Choice question which accessories were used to stabilize the patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Diego Stohrer, MSc.

CONTACT

[email protected]

Jannis Fischer, Dr.

CONTACT

[email protected]

+41445155331

Sponsors and collaborators

Lead sponsor

Positrigo AG

Industry

Collaborators

  • University of Leipzig
  • University of Zurich

Registry information

Official study title

Exploratory Study of NeuroLF, an Investigational Medical Device Without CE Marking for PET Imaging of the Human Brain

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
May 31, 2025

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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