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

Not Applicable

Recruiting

• Conditions: Brain Diseases
• Interventions: Device: Conventional PET scan; Device: NeuroLF

• Registration Number: NCT06344871
• Lead Sponsor: Positrigo AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-13
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-27
• Status Verified: 2024-04
• Study First Posted: 2024-04-03
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Comparator Scan	Conventional PET scan	Scan on a conventional clinical PET system.
NeuroLF Scan	NeuroLF	Scan on the NeuroLF PET system.

Primary Outcome Measures

Name	Time	Method
PET Image of the Brain	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 Outcome Measures

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

Trial Locations

Locations (2)

University Hospital Leipzig; 🇩🇪 Leipzig, Germany

University Hospital Zurich; 🇨🇭 Zürich, Switzerland