Menu
Recruiting NCT06344871

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

No phase Interventional Brain Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NeuroLF, Conventional PET scan.
Who it may be relevant to
Registry conditions: Brain Diseases. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device NeuroLF
    NeuroLF Scan
  • Device Conventional PET scan
    Scan on conventional PET system

Primary outcome measures

  • PET Image of the Brain [Time frame: 1 day]
Secondary outcome measures (2)
  • Ease of Placement (Usability) [Time frame: 1 day]
  • Usage of accessories for patient placement (Usability) [Time frame: 1 day]

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,
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Germany · 1 center
  • University Hospital Leipzig — Leipzig
Switzerland · 1 center
  • University Hospital Zurich — Zurich

Identifiers

NCT: NCT06344871 · 002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗