Clinical trial

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

Name

R18-179

Description

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.

Trial arms

Trial start

2021-10-05

Estimated PCD

2024-10-05

Trial end

2025-10-05

Status

Recruiting

Phase

Early phase I

Treatment

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

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.

Arms:

Chronic Fatigue Syndrome, Fibromyalgia, Healthy Controls, Multiple Sclerosis

Size

120

Primary endpoint

Regional brain distribution of radiolabeled white blood cells

3 years

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: 1. Contraindication to MRI 2. Pregnancy 3. Lactation 4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition 5. Chronic infectious disease (e.g. HIV, HCV) 6. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation 7. Diagnosis of cancer, including leukemia 8. Blood or blood clotting disorder 9. Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary 10. 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 11. Currently enrolled in a clinical trial utilizing experimental therapies 12. Contraindication to gadolinium based contrast agents

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

Updated at

2024-02-14

1 organization

1 product

4 indications

Organization

University of Alabama at Birmingham

Product

Zr-89 Oxine-labeled leukocytes

Indication

Fibromyalgia

Indication

Chronic Fatigue Syndrome

Indication

Multiple Sclerosis

Indication

Healthy