Exploring a new head-only PET scanner for brain diseases
Exploratory Study of NeuroLF, an Investigational Medical Device Without CE Marking for PET Imaging of the Human Brain
NA · Positrigo AG · NCT06344871
This study is testing a new type of brain scanner to see if it can safely use leftover tracer from a regular PET scan to help diagnose brain diseases.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Positrigo AG (industry) |
| Locations | 2 sites (Leipzig and 1 other locations) |
| Trial ID | NCT06344871 on ClinicalTrials.gov |
What this trial studies
This study evaluates the NeuroLF prototype, a small aperture PET scanner, by using it on patients who have just completed a standard whole body PET scan. The study aims to utilize the residual radioactive tracer activity from the initial scan for imaging with the NeuroLF, eliminating the need for an additional tracer dose. Participants will undergo a conventional brain PET scan as a control intervention immediately before the NeuroLF scan. The goal is to assess the effectiveness and safety of this new imaging approach in diagnosing brain diseases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who are scheduled for a routine brain PET scan and can remain still for 15 minutes.
Not a fit: Patients with contraindications to PET examinations, significant height or weight restrictions, or those unable to comply with study procedures may not benefit.
Why it matters
Potential benefit: If successful, this could lead to more efficient and safer imaging techniques for brain diseases.
How similar studies have performed: While this approach is innovative, similar studies using advanced PET imaging techniques have shown promise in improving diagnostic capabilities.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Leipzig and 1 other locations
- University Hospital Leipzig — Leipzig, Germany (RECRUITING)
- University Hospital Zurich — Zurich, Switzerland (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Jannis Fischer, Dr.
- Email: jannis.fischer@positrigo.com
- Phone: +41445155331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Diseases