No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
60 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 65 with multiple sclerosis or healthy volunteers. Participants will receive an imaging agent called 18F 3F4AP and undergo assessments to see how it works in the brain.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 64 years old.
I can understand and give informed consent.
You may not be able to join if
I have a known brain disease, like a tumor or stroke.
I have any device that is not MRI compatible.
I have severe claustrophobia.
I have kidney disease or diabetes.
I have had a bad reaction to gadolinium contrast.
I have an unstable physical or mental condition.
I cannot give written informed consent.
I have abnormal blood test results.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Our overall objective is to obtain an initial assessment of the potential value of using \[18F\]3F4AP for imaging demyelinating diseases such as multiple sclerosis:
* Aim 1) Assess the safety of \[18F\]3F4AP in healthy volunteers and subjects with multiple sclerosis (MS). Hypothesis 1: Administration of \[18F\]3F4AP will result in no changes in vitals or other adverse events.
* Aim 2) Assess the …
Our overall objective is to obtain an initial assessment of the potential value of using \[18F\]3F4AP for imaging demyelinating diseases such as multiple sclerosis:
* Aim 1) Assess the safety of \[18F\]3F4AP in healthy volunteers and subjects with multiple sclerosis (MS). Hypothesis 1: Administration of \[18F\]3F4AP will result in no changes in vitals or other adverse events.
* Aim 2) Assess the pharmacokinetics of a bolus infusion of \[18F\]3F4AP in humans including healthy volunteers and MS patients. Hypothesis 2: the pharmacokinetics of \[18F\]3F4AP at the whole brain level will be similar in controls and MS subjects. The kinetics in demyelinated lesions will be slower than in healthy control areas.
* Aim 3) Assess the reproducibility of \[18F\]3F4AP in humans. Hypothesis 3: the test/retest variability of \[18F\]3F4AP within the same subject will be lower than 10%.
* Aim 4) Correlate MR brain images with \[18F\]3F4AP PET brain 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 MS. Hypothesis 5: increased PET signal (VT or SUV) will correlate with impaired Single Digit Modality Test (SDMT) scores.
* Aim 6) Correlate \[18F\]3F4AP PET signal with EDSS score in people with MS. Hypothesis 6: increased PET signal (VT or SUV) will correlate with higher EDSS scores.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Subjects must be ≥18 and \<65 years of age;
* Able to understand and provide informed consent prior to study procedures
Exclusion Criteria:
* Subjects with known structural brain disease (e.g. brain tumor or stroke);
* Any contraindication to MRI and/or PET, including:
* …
Inclusion Criteria:
* Subjects must be ≥18 and \<65 years of age;
* Able to understand and provide informed consent prior to study procedures
Exclusion Criteria:
* Subjects with known structural brain disease (e.g. brain tumor or stroke);
* Any contraindication to MRI and/or PET, including:
* Subjects with life vest;
* Subjects with implanted heart device (e.g. ICD, Pacemaker);
* Subjects with metallic fragment or foreign body;
* Subjects with other form of devices or prosthesis that are not MRI compatible, such as insulin pump, joint replacement, hearing aid, cochlear implant, permanent contraceptive devices, etc.;
* Subjects with severe claustrophobia
* Relative or absolute contraindication to Dotarem contrast:
* history of renal disease including acute or chronic severe renal insufficiency (glomerular filtration rate \<60 mL/min/1.73m2);
* history of diabetes mellitus, systemic lupus, multiple myeloma, nephrogenic systemic fibrosis, and other co-morbidities;
* History of hypersensitive reactions to Dotarem and/or gadolinium contrast agent;
* Radiation exposure exceeds current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months);
* Female subjects only: Positive serum pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
* Inability to provide written informed consent;
* Any clinically significant acute or unstable physical or psychiatric condition, judged by the investigators based on medical history or screening physical examination, to be incompatible with the study;
* Any physical or psychiatric condition judged by the investigators to be incompatible with the study, based on medical history or screening physical examination;
* Abnormal results on blood tests judged by the investigators to be incompatible with the study.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.