Autoimmune DiseaseEarly Phase 1NCT02925351
Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases
A Early Phase 1 study testing Computed Tomography, Fluorine F 18 Clofarabine and Positron Emission Tomography in people with Autoimmune Disease and Crohn Disease, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Disease, Crohn Disease, Inflammatory Disorder
- What is being tested?
- Computed Tomography, Fluorine F 18 Clofarabine and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2016to 30 Apr 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 years or older.
- Diagnosed with an autoimmune and inflammatory disorder.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Autoimmune Disease, Crohn Disease, Inflammatory Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Takayasu Arteritis
- Being tested
- Computed Tomography, Fluorine F 18 Clofarabine, Positron Emission Tomography
- Medical subject headings
- Autoimmune Diseases, Crohn Disease, Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo PET/CT scan
Fluorine F 18 ClofarabineRadiation
Also called 18F-CA, 18F-Clofarabine, [18F]-Clofarabine, Cl-18F-ara-A
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan
Undergo PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| Imaging (fluorine F 18 clofarabine, PET/CT) | Experimental | Patients receive fluorine F 18 clofarabine IV and undergo a single PET/CT scan for up to 120 minutes. Receives: Procedure: Computed Tomography; Radiation: Fluorine F 18 Clofarabine; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Uptake Value
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.
Measured: Baseline up to 240 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start25 Jan 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseaseStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pilot
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Allen-Auerbach, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925351
- Sponsor's protocol ID
- 15-001600
- Other IDs
- NCI-2016-01303, 15-001600
- Status last verified
- Nov 2019
- First submitted
- 8 Sep 2016
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT02925351
- Acronym / sponsor ID
- 15-001600
- Conditions
- Autoimmune Disease, Crohn Disease, Inflammatory Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Takayasu Arteritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot
| Arm | Type | Receives |
|---|---|---|
| Imaging (fluorine F 18 clofarabine, PET/CT) | Experimental | Procedure: Computed Tomography, Radiation: Fluorine F 18 Clofarabine, Procedure: Positron Emission TomographyPatients receive fluorine F 18 clofarabine IV and undergo a single PET/CT scan for up to 120 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be 18 years or older.
- Diagnosed with an autoimmune and inflammatory disorder.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo PET/CT scan | Procedure or surgery | Imaging (fluorine F 18 clofarabine, PET/CT) |
| Fluorine F 18 ClofarabineAlso: 18F-CA, 18F-Clofarabine, [18F]-Clofarabine, Cl-18F-ara-AGiven IV | Radiation | Imaging (fluorine F 18 clofarabine, PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography ScanUndergo PET/CT scan | Procedure or surgery | Imaging (fluorine F 18 clofarabine, PET/CT) |
Primary outcome
Standardized Uptake Value
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Allen-Auerbach principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Computed Tomography, Fluorine F 18 Clofarabine and Positron Emission Tomography in people with Autoimmune Disease and Crohn Disease, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Uptake Value (time frame: Baseline up to 240 minutes after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.