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

NCT ID: NCT06344871

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Brain Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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NeuroLF Scan

Scan on the NeuroLF PET system.

Group Type EXPERIMENTAL

NeuroLF

Intervention Type DEVICE

NeuroLF Scan

Comparator Scan

Scan on a conventional clinical PET system.

Group Type ACTIVE_COMPARATOR

Conventional PET scan

Intervention Type DEVICE

Scan on conventional PET system

Interventions

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NeuroLF

NeuroLF Scan

Intervention Type DEVICE

Conventional PET scan

Scan on conventional PET system

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

University of Leipzig

OTHER

Sponsor Role collaborator

Positrigo AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Leipzig

Leipzig, , Germany

Site Status RECRUITING

University Hospital Zurich

Zurich, , Switzerland

Site Status NOT_YET_RECRUITING

Countries

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Germany Switzerland

Central Contacts

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Jannis Fischer, Dr.

Role: CONTACT

+41445155331

Diego Stohrer, MSc.

Role: CONTACT

Facility Contacts

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Henryk Barthel, Prof.Dr.

Role: primary

+49 341 97 18082

Martin Hüllner, Prof. Dr.

Role: primary

+41 44 255 25 80

Other Identifiers

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002

Identifier Type: -

Identifier Source: org_study_id

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