Back to resultsThe Biodistribution of 1-L-(2 Deoxy-2,- 18 Fluoroarabinofuranosyl) Cytosine ([18F]L-FAC) in Healthy Subjects and Patients With Cancer, Autoimmune and Inflammatory Diseases
Primary Purpose
Autoimmune Diseases, Cancer
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Autoimmune Diseases focused on measuring imaging probe, cancer, inflammatory tissue, inflammatory diseases
Eligibility Criteria
Inclusion Criteria:
- greater than 18 years of age
- women of childbearing potential will undergo a pregnancy test free of charge
- patients with hematological malignancies, solid tumors or autoimmune disorders
Sites / Locations
- UCLA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Arm Label
patients with cancer
patients with autoimmune dosorders
healthy subjects
Arm Description
patients with hematological malignancies and solid tumors
patients with Rheumatoid arthritis, Crohns's disease, systemic lupus erythematosus.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01180868
First Posted
August 11, 2010
Last Updated
July 27, 2012
Sponsor
Jonsson Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01180868
Brief Title
The Biodistribution of 1-L-(2 Deoxy-2,- 18 Fluoroarabinofuranosyl) Cytosine ([18F]L-FAC) in Healthy Subjects and Patients With Cancer, Autoimmune and Inflammatory Diseases
Official Title
The Biodistribution of 1-L-(2 Deoxy-2,- 18 Fluoroarabinofuranosyl) Cytosine ([18F]L-FAC) in Healthy Subjects and Patients With Cancer, Autoimmune and Inflammatory Diseases
Study Type
Observational
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the biodistribution of a new agent 1-L-(2 deoxy-2,-18fluoroarabinofuranosyl) cytosine non-invasively in healthy humans and to evaluate whether it can be used to image cancer, autoimmune disease, and inflammation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Diseases, Cancer
Keywords
imaging probe, cancer, inflammatory tissue, inflammatory diseases
7. Study Design
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with cancer
Arm Description
patients with hematological malignancies and solid tumors
Arm Title
patients with autoimmune dosorders
Arm Description
patients with Rheumatoid arthritis, Crohns's disease, systemic lupus erythematosus.
Arm Title
healthy subjects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
greater than 18 years of age
women of childbearing potential will undergo a pregnancy test free of charge
patients with hematological malignancies, solid tumors or autoimmune disorders
Study Population Description
Patients with cancer, patients with autoimmune dosorders, and healthy subjects.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiaan Schiepers, M.D. Ph.D
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Biodistribution of 1-L-(2 Deoxy-2,- 18 Fluoroarabinofuranosyl) Cytosine ([18F]L-FAC) in Healthy Subjects and Patients With Cancer, Autoimmune and Inflammatory Diseases
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