Exploratory study of NeuroLF, a medical trial product without CE marking for PET imaging of the human brain

Germany, Switzerland (ICTRP)

ICTRP Studien-ID
NCT06344871 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
EXPLORATORY STUDY OF NEUROLF, AN INVESTIGATIONAL MEDICAL DEVICE WITHOUT CE-MARKING FOR PET IMAGING OF THE HUMAN BRAIN (BASEC)

Wissenschaftlicher Titel
Exploratory Study of NeuroLF, an Investigational Medical Device Without CE Marking for PET Imaging of the Human Brain (ICTRP)

Öffentlicher Titel
Exploratory Study Using a New Head-only PET Scanner / ExploreNeuroLF (ICTRP)

Untersuchte Krankheit(en)
Brain Diseases (ICTRP)

Untersuchte Intervention
Device: NeuroLFDevice: Conventional PET scan (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)

Ein-/Ausschlusskriterien
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. (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
PET Image of the Brain (ICTRP)

Ease of Placement (Usability);Usage of accessories for patient placement (Usability) (ICTRP)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
University of Zurich;University of Leipzig (ICTRP)

Weitere Kontakte
Jannis Fischer, Dr., jannis.fischer@positrigo.com, +41445155331 (ICTRP)

Sekundäre IDs
002 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06344871 (ICTRP)