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Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.

Primary Purpose

Fibromyalgia, Chronic Fatigue Syndrome, Multiple Sclerosis

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

[Zr-89]Oxine-labeled leukocytes PET/MRI

About this trial

This is an interventional diagnostic trial for Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1.18 to 65 years of age 2.Healthy volunteer OR

Clinical diagnosis of Multiple Sclerosis (MS) OR
Meets 2016 American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR
Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome

Exclusion Criteria:

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
Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary
Positive urine pregnancy test day of procedure or a serum pregnancy test within 48 hours prior to the administration of Zirconium-89 Oxinate-4-labeled leukocytes
Currently enrolled in a clinical trial utilizing experimental therapies
Contraindication to gadolinium based contrast agents

Sites / Locations

UABRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Fibromyalgia

Chronic Fatigue Syndrome

Multiple Sclerosis

Healthy Controls

Arm Description

Outcomes

Primary Outcome Measures

Regional brain distribution of radiolabeled white blood cells

Descriptive statistics (means and standard deviations) of standardized uptake values (SUVs) will be presented for the patient groups and healthy controls in the following regions: whole brain, gray matter, white matter, atlas-based regions of interest, and lesions (MS patients only). Normality of the SUV distribution will be tested using Shapiro-Wilk tests, and the data will be transformed to normal distribution if necessary.

Secondary Outcome Measures

Full Information

NCT ID

NCT03807973

First Posted

January 14, 2019

Last Updated

December 16, 2022

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT03807973

Brief Title

Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.

Official Title

Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 5, 2021 (Actual)

Primary Completion Date

October 5, 2024 (Anticipated)

Study Completion Date

October 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will use brain Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) and an investigational radioactive drug called [Zr-89]oxine to track the location of white blood cells (also called leukocytes) in the body. PET/MRI will be used to visualize labeled white blood cells and determine if they enter the central nervous system in conditions associated with brain inflammation (also called neuroinflammation). By better understanding the role of neuroinflammation in fibromyalgia, chronic fatigue syndrome, and multiple sclerosis, the investigator hopes to be able to better diagnose and treat patients in the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia, Chronic Fatigue Syndrome, Multiple Sclerosis, Healthy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fibromyalgia

Arm Type

Experimental

Arm Title

Chronic Fatigue Syndrome

Arm Type

Experimental

Arm Title

Multiple Sclerosis

Arm Type

Experimental

Arm Title

Healthy Controls

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

[Zr-89]Oxine-labeled leukocytes PET/MRI

Intervention Description

All study participants will undergo an investigational imaging study using autologous [Zr-89]-labeled leukocytes and brain PET/MRI. Participants will undergo a venous blood draw, and the leukocytes in the blood sample will be isolated for labeling using [Zr-89]oxine. The labeled leukocytes (7.4- 18.5 megabecquerel (MBq), 200-500 uCi) will be re-injected into the participant followed by brain PET/MRI at 24-48 hours after injection. Participants will be asked to have a second brain imaging study 3-6 days after this injection, but this second imaging study is optional.

Primary Outcome Measure Information:

Title

Regional brain distribution of radiolabeled white blood cells

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1.18 to 65 years of age 2.Healthy volunteer OR Clinical diagnosis of Multiple Sclerosis (MS) OR Meets 2016 American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome Exclusion Criteria: 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 Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary Positive urine pregnancy test day of procedure or a serum pregnancy test within 48 hours prior to the administration of Zirconium-89 Oxinate-4-labeled leukocytes Currently enrolled in a clinical trial utilizing experimental therapies Contraindication to gadolinium based contrast agents

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jonathan McConathy, MD, PhD

Phone

205-996-7115

jmcconathy@uabmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Evan Hudson, BS

Phone

205-934-6499

evanhudson@uabmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan McConathy, MD,PhD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

UAB

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Evan Hudson, BS

Phone

205-934-6499

evanhudson@uabmc.edu

First Name & Middle Initial & Last Name & Degree

Jonathan McConathy, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.

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