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

Positrigo

Status: Enrolling

Conditions: Brain Diseases

Treatments: Device: NeuroLF; Device: Conventional PET scan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06344871

002

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

NeuroLF Scan

Experimental group

Description:

Scan on the NeuroLF PET system.

Treatment:

Device: NeuroLF

Comparator Scan

Active Comparator group

Description:

Scan on a conventional clinical PET system.

Treatment:

Device: Conventional PET scan