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

NCT06344871 | Recruiting

• 1 other identifier: 002
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

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 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.

  1 day

Secondary Outcomes (2)

• Ease of Placement (Usability)

  1 day

• Usage of accessories for patient placement (Usability)

  1 day

Study Arms (2)

NeuroLF Scan

EXPERIMENTAL

Scan on the NeuroLF PET system.

Device: NeuroLF

Comparator Scan

ACTIVE COMPARATOR

Scan on a conventional clinical PET system.

Device: Conventional PET scan

Interventions

NeuroLF DEVICE

NeuroLF Scan

NeuroLF Scan

Conventional PET scan DEVICE

Scan on conventional PET system

Comparator Scan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• 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,
• 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.

Sponsors & Collaborators

• Positrigo AG: lead
• University of Zurich: collaborator
• University of Leipzig: collaborator

Study Sites (2)

University Hospital Leipzig

Leipzig, Germany

RECRUITING

University Hospital Zurich

Zurich, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jannis Fischer, Dr.

CONTACT

+41445155331; jannis.fischer@positrigo.com

Diego Stohrer, MSc.

CONTACT

diego.stohrer@positrigo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 3, 2024
• Study Start: March 13, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); CH (1)