Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases

The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02925351

Enrollment

Registered

2016-10-05

Start date

2016-01-25

Completion date

2018-04-30

Last updated

2020-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Disease, Crohn Disease, Inflammatory Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Takayasu Arteritis

Brief summary

This pilot trial studies how well fluorine F 18 clofarabine positron emission tomography (PET)/computed tomography (CT) works in imaging patients with autoimmune or inflammatory diseases. Fluorine F 18 clofarabine is an imaging agent or tracer which may be taken up by inflammatory tissue in the body. Diagnostic imaging, such as PET/CT scans, can be used to measure the amount of injected tracer that is taken up by inflammatory tissue. PET/CT scan may help to determine how fluorine F 18 clofarabine is distributed throughout the body.

Detailed description

PRIMARY OBJECTIVES: I. Determine how fluorine F 18 clofarabine (18F-clofarabine) is distributed in the body, in patients with autoimmune and inflammatory diseases. II. Determine whether 18F-clofarabine can be used to image patients with autoimmune and inflammatory diseases. OUTLINE: Patients receive fluorine F 18 clofarabine intravenously (IV) and undergo a single PET/CT scan for up to 120 minutes.

Interventions

PROCEDUREComputed Tomography

Undergo PET/CT scan

RADIATIONFluorine F 18 Clofarabine

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT scan

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

pilot

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Must be 18 years or older. * Diagnosed with an autoimmune and inflammatory disorder.

Exclusion criteria

* Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge. * Patients unable to undergo or comply with PET/CT scanning due to pre-existing medical conditions including claustrophobia.

Design outcomes

Primary

Measure	Time frame	Description
Standardized Uptake Value	Baseline up to 240 minutes after injection	Standardized Uptake Value (SUV) will be the primary unit for assessment. Using standard PET/CT viewing software, the SUV will be measured for different organs and lesions of suspected disease and compared to reference/background tissues.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026