Evaluation of [¹⁸F]MODAG-009 PET Imaging in Synucleinopathies

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
MODAG GmbH
Study ID
NCT07640555
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • [¹⁸F]MODAG-009 PET imaging — DRUG
    Participants enrolled in the study will receive a single IV injection of \[¹⁸F\]MODAG-009 followed by dynamic PET imaging using the United Imaging NeuroEXPLORER (NX) brain PET scanner.

Study Details

This is a single-center, open-label clinical study designed to evaluate the imaging characteristics and safety of \[¹⁸F\]MODAG-009 in participants with Parkinson's disease (PD), Multiple system atrophy (MSA), and Healthy controls (HC). Approximately 13 participants will be enrolled in this study. Each participant will receive a single intravenous injection of \[¹⁸F\]MODAG-009, followed by PET imaging using the investigational United Imaging NeuroEXPLORER (NX) camera.

Key Dates

Start date
May 13, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Parkinson's disease (PD); Multiple system atrophy (MSA); Healthy controls (HC)
    Participants enrolled in the study will receive a single IV injection of up to up to 8 mCi of \[¹⁸F\]MODAG-009.

Primary Outcome Measure

Standard Uptake Value Ratios (SUVR) [ Time Frame: Up to 3 hours after tracer injection. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Institute for Neurodegenerative Disorders and XingImaging, LLCNew HavenConnecticut06510
Mackenzee George
[email protected]
475-318-8250 (24 hours)
Neha Prakash, MBBS (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Institute for Neurodegenerative Disorders and XingImaging, LLC· New Haven, CT

Related Studies