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

Germany, Switzerland (ICTRP)

ID di studio ICTRP
NCT06344871 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
EXPLORATORY STUDY OF NEUROLF, AN INVESTIGATIONAL MEDICAL DEVICE WITHOUT CE-MARKING FOR PET IMAGING OF THE HUMAN BRAIN (BASEC)

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

Titolo pubblico
Exploratory Study Using a New Head-only PET Scanner / ExploreNeuroLF (ICTRP)

Malattie studiate
Brain Diseases (ICTRP)

Intervento studiato
Device: NeuroLFDevice: Conventional PET scan (ICTRP)

Tipo di studio
Interventional (ICTRP)

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

Criteri di inclusione/esclusione
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)

non disponibile

Endpoint primari e secondari
PET Image of the Brain (ICTRP)

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

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
University of Zurich;University of Leipzig (ICTRP)

Contatti aggiuntivi
Jannis Fischer, Dr., jannis.fischer@positrigo.com, +41445155331 (ICTRP)

ID secondari
002 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06344871 (ICTRP)