NCT05656105

RecruitingEarly Phase 1

Positron Emission Tomography (PET) Imaging of Neuroinflammat...

University of Alabama at Birmingham Source

University of Alabama at Birmingham ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

IRB-300010479 R22-209

Study Type

interventional

Estimated enrollment

60

Locations

1 country

Sites

1

Timeline

Study Start

November 10, 2023

Actual (reported)

Primary Completion

June 1, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

June 1, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief Summary

This clinical imaging study will use the small molecule translocator protein (TSPO) ligand, Fluorodeoxyglucose(18F)-labeled DPA-714, to visualize and quantify neuroinflammation in individuals with post-acute sequelae of SARS-CoV-2 (PASC) . The brain uptake of DPA-714 will be contrasted with healthy subjects.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 60 participants
Study completion date: June 1, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 8, 2022
Actual (reported)
First Posted
December 19, 2022
Actual (reported)
Study Start
November 10, 2023
Actual (reported)
Primary Completion
June 1, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 1, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: August 12, 2026
Status Verified: August 2026
Last Update Submitted: August 10, 2026

Conditions

SARS CoV-2 Post-Acute Sequelae

Outcome Measures

Primary Outcomes (1)

Measurement of regional brain TSPO levels using PET in participants with neurological PASC and healthy volunteers
PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be quantified in symptomatic study participants and healthy volunteers will be collected and compared between groups
Injection/scan date to clinical follow-up. (Usually within 6 weeks)

Study Arms (2)

Healty Volunteers

EXPERIMENTAL

Drug: DPA-714 PET/MRI

PASC

EXPERIMENTAL

Patients meeting the case definition criteria for PASC

Drug: DPA-714 PET/MRI

Interventions

DPA-714 PET/MRIDrug

DPA-714 PET/MRI

Healty VolunteersPASC

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

to 65 years of age
Healthy volunteer OR Clinical diagnosis of post-acute sequelae of SARS-CoV-2 (PASC)

Sponsors & Collaborators

University of Alabama at Birmingham
Otherlead

Study Sites (1)

UAB

Birmingham, Alabama, 35249, United States

RECRUITING

April RiddleCONTACT2059961082 RadiologyCRC@uabmc.edu

Jonathan McConathy, MD, PhDPRINCIPAL INVESTIGATOR

Study Officials

Jonathan McConathy, MD, PhD
University of Alabama at Birmingham
PRINCIPAL INVESTIGATOR

Central Study Contacts

April Riddle

CONTACT

205-9961082 RadiologyCRC@uabmc.edu

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

December 8, 2022

First Posted

December 19, 2022

Study Start

November 10, 2023

Actual (reported)

Primary Completion

June 1, 2028

Estimated

High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.

PASC participants must have been previously infected with SARS-CoV-2. Their neurological symptoms must have been present for at least four weeks prior to the enrollment.

Healthy control participants must have no neurological symptoms

You may not qualify if:

Contraindication to MRI
Pregnancy
Lactation
Individuals who are unable to participate in the imaging portion due to severity of their medical condition
Chronic infectious disease (e.g. HIV, HCV)
Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
Diagnosis of cancer, including leukemia
Blood or blood clotting disorder
Positive urine β-hCG test day of procedure or a serum human chorionic gonadotropin (hCG) test within 48 hours prior to the administration of \[18F\]DPA-714.11.
Currently enrolled in a clinical trial utilizing experimental therapies. 12. Currently taking experimental therapies 13. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.

Contact the study team to confirm eligibility.

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

June 1, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05656105
Data provider: ClinicalTrials.gov
Source updated: 2026-08-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:55 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Healty Volunteers

PASC

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations