Exploring the Utility of [18F]3F4AP for Demyelination Imaging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [ 18F]3F4AP, [18F]MK6240, [11C]PIB.
- Who it may be relevant to
- Registry conditions: Demyelinating Disorders, MCI, Alzheimer's Disease (AD), MS (Multiple Sclerosis). Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The overall objective is to obtain an assessment of the pharmacokinetics of \[18F\]3F4AP in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (MCI), Alzheimer's Disease (AD), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and Spinal radiculopathy (SR).
Interventions
- Drug [ 18F]3F4AP
PET Scan #3 - Drug [18F]MK6240
PET Scan #2 - Drug [11C]PIB
PET Scan #1
Primary outcome measures
- Tracers volume of distribution (VT) [Time frame: 5 years]
- Distribution volume ratio (DVR) [Time frame: 5 years]
- Binding potential (BPND) [Time frame: 5 years]
- Demyelination [Time frame: 5 years]
- Tau burden [Time frame: 5 years]
- Amyloid burden [Time frame: 5 years]
- Tracer rate constant [Time frame: 5 years]
- Associations between imaging modalities and biomarkers. [Time frame: 5 years]
Secondary outcome measures (4)
- Measure of brain atrophy [Time frame: 5 years]
- Measure of cerebrovascular burden [Time frame: 5 years]
- Measure of White matter lesions (WML) [Time frame: 5 years]
- MR/MRSI images [Time frame: 5 years]
Eligibility criteria
Inclusion:
- Male and Female subjects must be ≥18 and <90 years of age;
- Able to understand and provide informed consent prior to study procedures
- Must be in good health
Exclusion:
- Less than 18 years of age;
- Pregnant or breastfeeding;
- Any significant systemic illness or unstable medical condition;
- Pre-existing medical conditions or claustrophobic reactions;
- Research-related radiation exposure exceeds current PET Center guidelines (i.e. 50 mSv in the prior 12 months);
- History of a bleeding disorder or are currently taking anticoagulants.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Yale University PET Center — New Haven
Identifiers
NCT: NCT06999434 · 2000039282 · 7P41EB022544-08 · 7R01EB033582-03 · 7R01AG076153-03 · 1R01AG085561-01