[18F]3F4AP Imaging for Brain Conditions

Overseen By Marc Normandin, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Massachusetts General Hospital

Disqualifiers: Pregnancy, Breastfeeding, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The overall objective is to obtain an initial assessment of the value of using \[18F\]3F4AP for imaging demyelinating diseases such as traumatic brain injury (TBI), neurodegenerative diseases such as mild cognitive impairment (MCI) and Alzheimer's Disease (AD): * Aim 1) Assess the safety of \[18F\]3F4AP in healthy volunteers and subjects with traumatic brain injury (TBI) and neurocognitive impaired subjects (AD/MCI). Hypothesis 1: Administration of \[18F\]3F4AP will result in no changes in vitals or other adverse events. * Aim 2) Assess the radiation doses to the main organs in healthy volunteers. Hypothesis 2: the radiation doses to each organ will be comparable in all subjects and within the acceptable limits. * Aim 3) Assess the pharmacokinetics of a bolus infusion of \[18F\]3F4AP in humans including healthy volunteers and patients. Hypothesis 3: the pharmacokinetics of \[18F\]3F4AP at the whole brain level will be similar in controls, TBI and AD/MCI subjects. The kinetics in demyelinated lesions will be slower than in healthy areas. * Aim 4) Correlate MR images with \[18F\]3F4AP PET images. Hypothesis 4A: all the lesions seen on the MRI will show increased signal (VT or SUV) on the PET images. Hypothesis 4B: some of the lesions on the MRI will show increased signal (VT or SUV) on the PET but not all. * Aim 5) Correlate \[18F\]3F4AP PET signal with neuropsychological testing in people with TBI and AD/MCI. Hypothesis 5A: increased PET signal (VT or SUV) will correlate with impaired Mini Mental State Examination (MMSE).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the [18F]3F4AP imaging treatment differ from other treatments for brain conditions?

[18F]3F4AP imaging is unique because it uses a PET tracer to visualize specific brain conditions, potentially offering higher resolution and more detailed imaging compared to standard MRI or CT scans. This approach can help in better understanding and tracking the progression of brain conditions, which is not typically possible with conventional imaging techniques. ^{1 2 3 4 5}

Who Is on the Research Team?

Marc Normandin, PhD

Principal Investigator

Mass. General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18, except those with Alzheimer's who should be aged 60-90. It's not suitable for pregnant or breastfeeding women, anyone trying to get pregnant, or individuals ineligible for PET/CT or MRI studies.

Exclusion Criteria

I am not pregnant, trying to get pregnant, or breastfeeding.

A subject will not be eligible for inclusion in this study if any of the exclusion criteria for PET/CT or MRI studies applies

A negative STAT quantitative serum hCG pregnancy test is required on the day of the PET/CT scan before female subjects of childbearing potential can participate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety and Dosimetry Assessment

Assess the safety of [18F]3F4AP and radiation doses to main organs in healthy volunteers and subjects with TBI and neurocognitive impairment

8 weeks

Multiple visits for imaging and safety assessments

Pharmacokinetics and Imaging Correlation

Assess pharmacokinetics of [18F]3F4AP and correlate MR images with PET images

12 weeks

Regular imaging sessions and neuropsychological testing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• F18-3F4AP

Trial Overview [18F]3F4AP is being tested to see if it can help image brain conditions like traumatic brain injury and neurodegenerative diseases. The study will check its safety, radiation doses in organs, how the body processes it, and compare imaging results with neuropsychological tests.

How Is the Trial Designed?

Group I: Traumatic Brain Injury Experimental Treatment 1 Intervention

Group II: Safety/Dosimetry Cohort Experimental Treatment 1 Intervention

Group III: AD/MCI Experimental Treatment 1 Intervention

Group IV: Healthy Controls Active Control 1 Intervention

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

The preclinical studies showed that [18F]MK-6240 is safe for use, with no adverse effects observed in rats at doses up to 1000 times the anticipated clinical dose, indicating a strong safety profile for human use.

In human studies, [18F]MK-6240 demonstrated effective biodistribution for brain imaging, with a low effective dose of 5.4 mSv per scan, allowing for multiple imaging sessions per year without significant risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Safety Evaluation and Human Dosimetry of [18F]MK-6240, a Novel PET Tracer for Imaging Neurofibrillary Tangles. Koole, M., Lohith, TG., Valentine, JL., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Hybrid PET/MRI enables high-spatial resolution, quantitative imaging of amyloid plaques in an Alzheimer's disease mouse model. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Amyloid imaging using fluorine-19 magnetic resonance imaging ((19)F-MRI). [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Hybrid PET-MRI Imaging in Paediatric and TYA Brain Tumours: Clinical Applications and Challenges. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Preclinical Safety Evaluation and Human Dosimetry of [18F]MK-6240, a Novel PET Tracer for Imaging Neurofibrillary Tangles. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Quantification of β-Amyloidosis and rCBF with Dedicated PET, 7 T MR Imaging, and High-Resolution Microscopic MR Imaging at 16.4 T in APP23 Mice. [2020]