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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Diseases
• Intervention / Treatment: Device: NeuroLF; Device: Conventional PET scan

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jannis Fischer, Dr.; Phone Number: +41445155331; Email: jannis.fischer@positrigo.com
• Study Contact Backup: Name: Diego Stohrer, MSc.; Email: diego.stohrer@positrigo.com

Study Locations

• Germany
  • Leipzig, Germany
    • Recruiting
    • University Hospital Leipzig
    • Contact: Henryk Barthel, Prof.Dr.; Phone Number: +49 341 97 18082; Email: Henryk.Barthel@medizin.uni-leipzig.de
    • Principal Investigator: Henryk Barthel, Prof. Dr.
• Switzerland
  • Zürich, Switzerland
    • Not yet recruiting
    • University Hospital Zurich
    • Contact: Martin Hüllner, Prof. Dr.; Phone Number: +41 44 255 25 80; Email: martin.huellner@usz.ch
    • Principal Investigator: Martin Hüllner, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NeuroLF Scan; Scan on the NeuroLF PET system.	Device: NeuroLF; NeuroLF Scan
Active Comparator: Comparator Scan; Scan on a conventional clinical PET system.	Device: Conventional PET scan; Scan on conventional PET system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Placement (Usability)	100-Visual Analog Scale question how easy it was to place the patient on NeuroLF vs. the comparator	1 day
Usage of accessories for patient placement (Usability)	Multiple Choice question which accessories were used to stabilize the patient.	1 day

Collaborators and Investigators

• Sponsor: Positrigo AG
• Collaborators: University of Zurich; University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Brain Diseases
• Other Study ID Numbers: 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No