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Exploring the Utility of [18F]3F4AP for Demyelination Imaging

NCT ID: NCT06999434

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2030-05-05

Brief Summary

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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).

Detailed Description

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Conditions

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Demyelinating Disorders MCI Alzheimer's Disease (AD) MS (Multiple Sclerosis) SCI - Spinal Cord Injury Spinal Radiculopathy

Keywords

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3F4AP Demyelinating Disorders MS SCI AD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Control

n = 30 - up to three PET scanning sessions.

Group Type ACTIVE_COMPARATOR

[ 18F]3F4AP

Intervention Type DRUG

PET Scan #3

[18F]MK6240

Intervention Type DRUG

PET Scan #2

[11C]PIB

Intervention Type DRUG

PET Scan #1

Alzheimer's Disease (AD)

n = 15 - up to three PET scanning sessions.

Group Type EXPERIMENTAL

[ 18F]3F4AP

Intervention Type DRUG

PET Scan #3

[18F]MK6240

Intervention Type DRUG

PET Scan #2

[11C]PIB

Intervention Type DRUG

PET Scan #1

Mild Cognitive Impairment (MCI)

n = 15 - up to three PET scanning sessions.

Group Type EXPERIMENTAL

[ 18F]3F4AP

Intervention Type DRUG

PET Scan #3

[18F]MK6240

Intervention Type DRUG

PET Scan #2

[11C]PIB

Intervention Type DRUG

PET Scan #1

Multiple Sclerosis (MS)

n = 15 - up to three PET scanning sessions.

Group Type EXPERIMENTAL

[ 18F]3F4AP

Intervention Type DRUG

PET Scan #3

[18F]MK6240

Intervention Type DRUG

PET Scan #2

[11C]PIB

Intervention Type DRUG

PET Scan #1

Spinal Cord Injury (SCI)

n = 15 - up to three PET scanning sessions.

Group Type EXPERIMENTAL

[ 18F]3F4AP

Intervention Type DRUG

PET Scan #3

[18F]MK6240

Intervention Type DRUG

PET Scan #2

[11C]PIB

Intervention Type DRUG

PET Scan #1

Spinal radiculopathy (SR)

n = 15 - up to three PET scanning sessions.

Group Type EXPERIMENTAL

[ 18F]3F4AP

Intervention Type DRUG

PET Scan #3

[18F]MK6240

Intervention Type DRUG

PET Scan #2

[11C]PIB

Intervention Type DRUG

PET Scan #1

Interventions

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[ 18F]3F4AP

PET Scan #3

Intervention Type DRUG

[18F]MK6240

PET Scan #2

Intervention Type DRUG

[11C]PIB

PET Scan #1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and Female subjects must be ≥18 and \<90 years of age;
2. Able to understand and provide informed consent prior to study procedures
3. Must be in good health

Exclusion:

1. Less than 18 years of age;
2. Pregnant or breastfeeding;
3. Any significant systemic illness or unstable medical condition;
4. Pre-existing medical conditions or claustrophobic reactions;
5. Research-related radiation exposure exceeds current PET Center guidelines (i.e. 50 mSv in the prior 12 months);
6. History of a bleeding disorder or are currently taking anticoagulants.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Georges El Fakhri

Professor of Radiology and Biomedical Imaging and of Biomedical Informatics & Data Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georges El Fakhri, PhD, DABR

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University PET Center

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shannan Henry

Role: CONTACT

Phone: +1 (203) 737-5278

Email: [email protected]

Kayla Cottiers

Role: CONTACT

Phone: 203-737-7496

Email: [email protected]

Other Identifiers

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7P41EB022544-08

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7R01EB033582-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7R01AG076153-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01AG085561-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000039282

Identifier Type: -

Identifier Source: org_study_id